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Guaifenesin
Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from
public FDA and NLM data. Always confirm against the manufacturer's current
prescribing information. Report adverse events to FDA MedWatch.
Overview
Brand name
Guaifenesin
Generic name
Guaifenesin
Dosage form
Tablet, Extended Release
Route
—
Marketing category
ANDA · ANDA
Labeler
Aurohealth LLC
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
42
Packages
87
Data completeness
82%
of corroborating sources present
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryDosage form
Tablet, Extended Release
Route of administration
—
Presentations
129
Pharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Decreased Respiratory Secretion Viscosity [PE] | PE | All 52 members |
| Expectorant [EPC] | EPC | All 48 members |
| Increased Respiratory Secretions [PE] | PE | All 48 members |
Regulatory status
Source: Drugs@FDANDC DirectoryApplication number
210453
Application type
ANDA · Abbreviated New Drug Application
Approval date
October 21, 2019
Sponsor
AUROBINDO PHARMA
Products on application
2
Submissions recorded
1
| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 210453-001 | GUAIFENESIN | TABLET, EXTENDED RELEASE | GUAIFENESIN | Over-the-counter | — | ||
| 210453-002 | GUAIFENESIN | TABLET, EXTENDED RELEASE | GUAIFENESIN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Original application | 1 | Approved | October 21, 2019 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260423). This is the manufacturer's labelling text, not a summary and not advice.
HUMAN OTC DRUG · 20260423 HUMAN OTC DRUG · 20260201 HUMAN OTC DRUG · 20251222 HUMAN OTC DRUG · 20241007
Indications and Usage
openFDA Drug LabelingUSE(S) • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose
openFDA Drug LabelingPurpose Expectorant
Dosage and Administration
openFDA Drug LabelingDirections 600 mg do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours. children under 12 years of age: do not use 1200 mg do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours. children under 12 years of age: do not use
Warnings
openFDA Drug LabelingWarnings Do not use for children under 12 years of age Ask a doctor before use if you have persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. Pregnancy/Breastfeeding If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Do Not Use
openFDA Drug LabelingDo not use • for children under 12 years of age
Ask a Doctor
openFDA Drug LabelingASK A DOCTOR BEFORE USE IF YOU HAVE • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema • cough accompanied by too much phlegm (mucus)
Stop Use
openFDA Drug LabelingStop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Active Ingredient
openFDA Drug LabelingActive ingredient(s) Active ingredient (in each extended-release tablet) Guaifenesin 600 mg Active ingredient (in each extended-release tablet) Guaifenesin 1200 mg
Adverse event reports
Source: openFDA FAERS202,963
FAERS reports mentioning this drug
A report count is not a risk measure. FAERS accepts voluntary and
mandatory reports without establishing causation, and reporting is influenced by how
widely a drug is used, how long it has been marketed, and media attention. FDA states
that reports “do not prove that the drug caused the event”. Compare rates, not totals.
Attributed to this product's most-reported active ingredient: GUAIFENESIN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 46122-750-51 | 46122-750 | AMERISOURCE BERGEN | 2 BLISTER PACK in 1 CARTON (46122-750-51) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 11, 2023 |
| 80513-413-11 | 80513-413 | Advanced Rx LLC | 110 TABLET, EXTENDED RELEASE in 1 BOTTLE (80513-413-11) | July 1, 2025 |
| 52493-036-89 | 52493-036 | Amneal Pharmaceuticals Co. (I) Pvt. Ltd. | 11 kg in 1 DRUM (52493-036-89) | April 10, 2024 |
| 52493-037-89 | 52493-037 | Amneal Pharmaceuticals Co. (I) Pvt. Ltd. | 11 kg in 1 DRUM (52493-037-89) | April 10, 2024 |
| 65162-036-02 | 65162-036 | Amneal Pharmaceuticals LLC | 2 BLISTER PACK in 1 CARTON (65162-036-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 27, 2018 |
| 65162-036-03 | 65162-036 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-036-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE | July 27, 2018 |
| 65162-036-06 | 65162-036 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-036-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE | July 27, 2018 |
| 65162-037-03 | 65162-037 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-037-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE | July 27, 2018 |
| 65162-037-06 | 65162-037 | Amneal Pharmaceuticals LLC | 1 BOTTLE in 1 CARTON (65162-037-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE | July 27, 2018 |
| 65162-037-28 | 65162-037 | Amneal Pharmaceuticals LLC | 2 BLISTER PACK in 1 CARTON (65162-037-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 27, 2018 |
| 59651-106-11 | 59651-106 | Aurobindo Pharma Limited | 1000 TABLET, EXTENDED RELEASE in 1 BAG (59651-106-11) | October 21, 2019 |
| 59651-107-82 | 59651-107 | Aurobindo Pharma Limited | 800 TABLET, EXTENDED RELEASE in 1 BAG (59651-107-82) | October 21, 2019 |
| 58602-810-12 | 58602-810 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-810-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE | October 21, 2019 |
| 58602-810-21 | 58602-810 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-810-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE | October 21, 2019 |
| 58602-810-38 | 58602-810 | Aurohealth LLC | 8 BLISTER PACK in 1 CARTON (58602-810-38) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 7, 2022 |
| 58602-810-73 | 58602-810 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-810-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE | October 21, 2019 |
| 58602-810-96 | 58602-810 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-810-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 21, 2019 |
| 58602-810-97 | 58602-810 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-810-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 21, 2019 |
| 58602-810-98 | 58602-810 | Aurohealth LLC | 5 BLISTER PACK in 1 CARTON (58602-810-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 21, 2019 |
| 58602-811-01 | 58602-811 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-811-01) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 21, 2019 |
| 58602-811-02 | 58602-811 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-811-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 21, 2019 |
| 58602-811-03 | 58602-811 | Aurohealth LLC | 3 BLISTER PACK in 1 CARTON (58602-811-03) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 21, 2019 |
| 58602-811-05 | 58602-811 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-811-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE | October 21, 2019 |
| 58602-811-12 | 58602-811 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-811-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE | October 21, 2019 |
| 58602-811-21 | 58602-811 | Aurohealth LLC | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-811-21) | October 21, 2019 |
| 58602-811-56 | 58602-811 | Aurohealth LLC | 4 BLISTER PACK in 1 CARTON (58602-811-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | January 31, 2020 |
| 58602-811-57 | 58602-811 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-811-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE | October 21, 2019 |
| 58602-811-60 | 58602-811 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-811-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE | October 21, 2019 |
| 58602-811-64 | 58602-811 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-811-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 26, 2020 |
| 58602-811-73 | 58602-811 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-811-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE | October 21, 2019 |
| 58602-853-12 | 58602-853 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-853-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE | August 13, 2020 |
| 58602-853-21 | 58602-853 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-853-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE | August 13, 2020 |
| 58602-853-73 | 58602-853 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-853-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE | August 13, 2020 |
| 58602-853-96 | 58602-853 | Aurohealth LLC | 1 BLISTER PACK in 1 CARTON (58602-853-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 13, 2020 |
| 58602-853-97 | 58602-853 | Aurohealth LLC | 2 BLISTER PACK in 1 CARTON (58602-853-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | August 13, 2020 |
| 58602-853-98 | 58602-853 | Aurohealth LLC | 5 BLISTER PACK in 1 CARTON (58602-853-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | November 1, 2022 |
| 58602-857-93 | 58602-857 | Aurohealth LLC | 6 BLISTER PACK in 1 CARTON (58602-857-93) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 3, 2026 |
| 58602-864-98 | 58602-864 | Aurohealth LLC | 5 BLISTER PACK in 1 CARTON (58602-864-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 11, 2021 |
| 58602-865-03 | 58602-865 | Aurohealth LLC | 3 BLISTER PACK in 1 CARTON (58602-865-03) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 11, 2021 |
| 21130-179-67 | 21130-179 | Better Living Brands LLC | 1 BLISTER PACK in 1 CARTON (21130-179-67) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 15, 2022 |
| 68001-561-17 | 68001-561 | BluePoint Laboratories | 8 BLISTER PACK in 1 CARTON (68001-561-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68001-561-16) | March 15, 2023 |
| 51316-071-68 | 51316-071 | CVS | 1 BLISTER PACK in 1 CARTON (51316-071-68) / 68 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | October 7, 2022 |
| 69842-335-16 | 69842-335 | CVS PHARMACY, INC | 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-16) | March 1, 2021 |
| 69842-335-28 | 69842-335 | CVS PHARMACY, INC | 28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-28) | March 1, 2021 |
| 69842-335-42 | 69842-335 | CVS PHARMACY, INC | 42 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69842-335-42) | March 1, 2021 |
| 43598-008-10 | 43598-008 | Dr. Reddy's Laboratories Inc. | 1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-008-10) | March 15, 2022 |
| 43598-008-89 | 43598-008 | Dr. Reddy's Laboratories Inc. | 1280 TABLET, EXTENDED RELEASE in 1 CASE (43598-008-89) | July 18, 2023 |
| 43598-008-97 | 43598-008 | Dr. Reddy's Laboratories Inc. | 64 BLISTER PACK in 1 CASE (43598-008-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20) | July 25, 2023 |
| 43598-009-10 | 43598-009 | Dr. Reddy's Laboratories Inc. | 1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-009-10) | March 15, 2022 |
| 70010-199-05 | 70010-199 | GRANULES PHARMACEUTICALS INC. | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-199-05) | August 19, 2022 |
| 69848-017-02 | 69848-017 | GRANULES USA, INC. | 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69848-017-02) | January 6, 2022 |
| 69848-018-16 | 69848-018 | GRANULES USA, INC. | 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (69848-018-16) | September 12, 2024 |
| 62207-569-93 | 62207-569 | Granules India Ltd | 5 POUCH in 1 BOX (62207-569-93) / 2000 TABLET, EXTENDED RELEASE in 1 POUCH | November 17, 2021 |
| 62207-569-99 | 62207-569 | Granules India Ltd | 4200 TABLET, EXTENDED RELEASE in 1 BAG (62207-569-99) | February 1, 2021 |
| 62207-570-30 | 62207-570 | Granules India Ltd | 20000 TABLET, EXTENDED RELEASE in 1 BAG (62207-570-30) | February 1, 2021 |
| 62207-570-31 | 62207-570 | Granules India Ltd | 5400 TABLET, EXTENDED RELEASE in 1 BAG (62207-570-31) | September 30, 2021 |
| 62207-570-92 | 62207-570 | Granules India Ltd | 4000 TABLET, EXTENDED RELEASE in 1 BAG (62207-570-92) | February 1, 2021 |
| 62207-839-72 | 62207-839 | Granules India Ltd | 9 BLISTER PACK in 1 CARTON (62207-839-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 18, 2020 |
| 62207-840-71 | 62207-840 | Granules India Ltd | 7 BLISTER PACK in 1 CARTON (62207-840-71) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 18, 2020 |
| 62207-840-93 | 62207-840 | Granules India Ltd | 10000 TABLET, EXTENDED RELEASE in 1 BOX (62207-840-93) | October 31, 2022 |
| 62207-840-99 | 62207-840 | Granules India Ltd | 4200 TABLET, EXTENDED RELEASE in 1 BAG (62207-840-99) | December 18, 2020 |
| 30142-961-20 | 30142-961 | Kroger Company | 1 BLISTER PACK in 1 CARTON (30142-961-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 28, 2022 |
| 30142-962-14 | 30142-962 | Kroger Company | 1 BLISTER PACK in 1 CARTON (30142-962-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 20, 2022 |
| 51660-566-21 | 51660-566 | Ohm Laboratories, Inc. | 20 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-21) | April 1, 2022 |
| 51660-566-41 | 51660-566 | Ohm Laboratories, Inc. | 40 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-41) | April 1, 2022 |
| 51660-566-68 | 51660-566 | Ohm Laboratories, Inc. | 68 TABLET, EXTENDED RELEASE in 1 CARTON (51660-566-68) | January 17, 2026 |
| 51660-567-54 | 51660-567 | Ohm Laboratories, Inc. | 14 TABLET, EXTENDED RELEASE in 1 CARTON (51660-567-54) | April 1, 2022 |
| 51660-567-58 | 51660-567 | Ohm Laboratories, Inc. | 56 TABLET, EXTENDED RELEASE in 1 CARTON (51660-567-58) | April 1, 2022 |
| 51660-567-86 | 51660-567 | Ohm Laboratories, Inc. | 28 TABLET, EXTENDED RELEASE in 1 CARTON (51660-567-86) | April 1, 2022 |
| 41415-997-14 | 41415-997 | PUBLIX SUPER MARKETS, INC | 1 BLISTER PACK in 1 CARTON (41415-997-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | December 10, 2017 |
| 82804-265-20 | 82804-265 | Proficient Rx LP | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-265-20) | February 2, 2026 |
| 41415-996-20 | 41415-996 | Publix Super Markets, Inc | 1 BLISTER PACK in 1 CARTON (41415-996-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | February 8, 2018 |
| 11822-4260-1 | 11822-4260 | RITE AID CORPORATION | 1 BLISTER PACK in 1 CARTON (11822-4260-1) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 29, 2022 |
| 11822-4260-2 | 11822-4260 | RITE AID CORPORATION | 2 BLISTER PACK in 1 CARTON (11822-4260-2) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 29, 2022 |
| 11822-4260-3 | 11822-4260 | RITE AID CORPORATION | 3 BLISTER PACK in 1 CARTON (11822-4260-3) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 29, 2022 |
| 68196-996-56 | 68196-996 | SAM'S WEST INC | 4 BLISTER PACK in 1 CARTON (68196-996-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | January 12, 2022 |
| 71309-461-56 | 71309-461 | Safrel Pharmaceuticals, LLC. | 56 TABLET, EXTENDED RELEASE in 1 BOTTLE (71309-461-56) | June 29, 2022 |
| 68196-960-56 | 68196-960 | Sam's West Inc | 4 BLISTER PACK in 1 CARTON (68196-960-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | July 31, 2025 |
| 76162-031-56 | 76162-031 | TOPCO ASSOCIATES LLC | 4 BLISTER PACK in 1 CARTON (76162-031-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 22, 2026 |
| 71179-002-21 | 71179-002 | VESPYR BRANDS LLC | 3 BLISTER PACK in 1 CARTON (71179-002-21) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | June 27, 2022 |
| 0363-0028-96 | 0363-0028 | WALGREEN CO. | 1 BLISTER PACK in 1 CARTON (0363-0028-96) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 8, 2020 |
| 0363-0028-97 | 0363-0028 | WALGREEN CO. | 2 BLISTER PACK in 1 CARTON (0363-0028-97) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 8, 2020 |
| 0363-0028-98 | 0363-0028 | WALGREEN CO. | 5 BLISTER PACK in 1 CARTON (0363-0028-98) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 8, 2020 |
| 0363-0033-01 | 0363-0033 | WALGREEN CO. | 1 BLISTER PACK in 1 CARTON (0363-0033-01) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 8, 2020 |
| 0363-0033-02 | 0363-0033 | WALGREEN CO. | 2 BLISTER PACK in 1 CARTON (0363-0033-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | May 8, 2020 |
| 0363-0033-03 | 0363-0033 | WALGREEN CO. | 3 BLISTER PACK in 1 CARTON (0363-0033-03) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 1, 2021 |
| 79903-124-20 | 79903-124 | Walmart Stores, Inc. | 1 BLISTER PACK in 1 CARTON (79903-124-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | April 28, 2022 |
| 46122-750 | 46122-750 | AMERISOURCE BERGEN | — | August 11, 2023 |
| 80513-413 | 80513-413 | Advanced Rx LLC | — | December 18, 2020 |
| 52493-036 | 52493-036 | Amneal Pharmaceuticals Co. (I) Pvt. Ltd. | — | April 10, 2024 |
| 52493-037 | 52493-037 | Amneal Pharmaceuticals Co. (I) Pvt. Ltd. | — | April 10, 2024 |
| 65162-036 | 65162-036 | Amneal Pharmaceuticals LLC | — | July 27, 2018 |
| 65162-037 | 65162-037 | Amneal Pharmaceuticals LLC | — | July 27, 2018 |
| 59651-106 | 59651-106 | Aurobindo Pharma Limited | — | October 21, 2019 |
| 59651-107 | 59651-107 | Aurobindo Pharma Limited | — | October 21, 2019 |
| 58602-810 | 58602-810 | Aurohealth LLC | — | October 21, 2019 |
| 58602-811 | 58602-811 | Aurohealth LLC | — | October 21, 2019 |
| 58602-853 | 58602-853 | Aurohealth LLC | — | August 13, 2020 |
| 58602-857 | 58602-857 | Aurohealth LLC | — | July 3, 2026 |
| 58602-864 | 58602-864 | Aurohealth LLC | — | March 11, 2021 |
| 58602-865 | 58602-865 | Aurohealth LLC | — | March 11, 2021 |
| 21130-179 | 21130-179 | Better Living Brands LLC | — | April 15, 2022 |
| 68001-561 | 68001-561 | BluePoint Laboratories | — | March 15, 2023 |
| 51316-071 | 51316-071 | CVS | — | October 7, 2022 |
| 69842-335 | 69842-335 | CVS PHARMACY, INC | — | March 1, 2021 |
| 43598-008 | 43598-008 | Dr. Reddy's Laboratories Inc. | — | March 15, 2022 |
| 70010-199 | 70010-199 | GRANULES PHARMACEUTICALS INC. | — | August 19, 2022 |
| 69848-017 | 69848-017 | GRANULES USA, INC. | — | December 31, 2021 |
| 69848-018 | 69848-018 | GRANULES USA, INC. | — | September 12, 2024 |
| 62207-569 | 62207-569 | Granules India Ltd | — | February 1, 2021 |
| 62207-570 | 62207-570 | Granules India Ltd | — | February 1, 2021 |
| 62207-839 | 62207-839 | Granules India Ltd | — | December 18, 2020 |
| 62207-840 | 62207-840 | Granules India Ltd | — | December 18, 2020 |
| 30142-961 | 30142-961 | Kroger Company | — | April 28, 2022 |
| 30142-962 | 30142-962 | Kroger Company | — | April 20, 2022 |
| 51660-566 | 51660-566 | Ohm Laboratories, Inc. | — | April 1, 2022 |
| 51660-567 | 51660-567 | Ohm Laboratories, Inc. | — | April 1, 2022 |
| 41415-997 | 41415-997 | PUBLIX SUPER MARKETS, INC | — | December 10, 2017 |
| 82804-265 | 82804-265 | Proficient Rx LP | — | August 19, 2022 |
| 41415-996 | 41415-996 | Publix Super Markets, Inc | — | January 8, 2018 |
| 11822-4260 | 11822-4260 | RITE AID CORPORATION | — | June 29, 2022 |
| 68196-996 | 68196-996 | SAM'S WEST INC | — | January 12, 2022 |
| 71309-461 | 71309-461 | Safrel Pharmaceuticals, LLC. | — | December 18, 2020 |
| 68196-960 | 68196-960 | Sam's West Inc | — | July 31, 2025 |
| 76162-031 | 76162-031 | TOPCO ASSOCIATES LLC | — | April 22, 2026 |
| 71179-002 | 71179-002 | VESPYR BRANDS LLC | — | June 27, 2022 |
| 0363-0028 | 0363-0028 | WALGREEN CO. | — | May 8, 2020 |
| 0363-0033 | 0363-0033 | WALGREEN CO. | — | May 8, 2020 |
| 79903-124 | 79903-124 | Walmart Stores, Inc. | — | April 28, 2022 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.