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Guaifenesin and Dextromethorphan HBr

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 and Dextromethorphan HBr
Generic name
Guaifenesin and Dextromethorphan HBr
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Dr. Reddy's Laboratories Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
6
NDC product codes
32
Packages
80
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Dextromethorphan Hydrobromide 1 kg/kg 1094538 View
Dextromethorphan Hydrobromide 30 mg/1 1094538 View
Dextromethorphan Hydrobromide 60 mg/1 1094538 View
Guaifenesin 1 kg/kg 359601 View
Guaifenesin 1200 mg/1 359601 View
Guaifenesin 600 mg/1 359601 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
112

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
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
Sigma-1 Agonist [EPC] EPC All 44 members
Sigma-1 Receptor Agonists [MoA] MoA All 44 members
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] EPC All 44 members
Uncompetitive NMDA Receptor Antagonists [MoA] MoA All 44 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
206941
Application type
ANDA · Abbreviated New Drug Application
Approval date
March 17, 2017
Sponsor
AUROBINDO PHARMA
Products on application
2
Submissions recorded
1
Products approved under application 206941.
Product Trade name Form Strength Ingredient Status TE Flags
206941-001 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN Over-the-counter —
206941-002 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE TABLET, EXTENDED RELEASE DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 206941.
Type No. Action Status Date Review
Original application 1 Approved March 17, 2017 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251130). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251130 HUMAN OTC DRUG · 20221206 HUMAN OTC DRUG · 20220524

Indications and Usage

openFDA Drug Labeling

Uses • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive • temporarily relieves: • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants • the intensity of coughing • the impulse to cough to help you get to sleep

Active ingredients (in each extended-release tablet) Purposes Dextromethorphan HBr 60 mg Cough suppressant Guaifenesin 1,200 mg Expectorant

Dosage and Administration

openFDA Drug Labeling

Directions do not crush, chew, or break extended-release tablet take with a full glass of water this product can be administered without regard for timing of meals children under 12 years of age: do not use For 600 mg/30 mg: adults and children 12 years and older: 1 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours. For 1200 mg/60 mg: adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours.

Warnings Do not use • for children under 12 years of age • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. 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) When using this product • Do not use more than directed 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 or Breast Feeding 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 for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a Doctor

openFDA Drug Labeling

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.

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each extended-release tablet) Guaifenesin USP, 600 mg Dextromethorphan Hydrobromide USP, 30 mg Guaifenesin USP, 1200 mg Dextromethorphan Hydrobromide USP, 60 mg

Adverse event reports

Source: openFDA FAERS
202,963
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
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
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
52493-038-89 52493-038 Amneal Pharmaceuticals Co. (I) Pvt. Ltd. 12 kg in 1 DRUM (52493-038-89) July 3, 2024
52493-039-89 52493-039 Amneal Pharmaceuticals Co. (I) Pvt. Ltd. 11 kg in 1 DRUM (52493-039-89) July 3, 2024
65162-038-03 65162-038 Amneal Pharmaceuticals LLC 1 BOTTLE in 1 CARTON (65162-038-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE November 1, 2018
65162-038-06 65162-038 Amneal Pharmaceuticals LLC 1 BOTTLE in 1 CARTON (65162-038-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE November 1, 2018
65162-038-17 65162-038 Amneal Pharmaceuticals LLC 2 BLISTER PACK in 1 CARTON (65162-038-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK November 1, 2018
65162-039-03 65162-039 Amneal Pharmaceuticals LLC 1 BOTTLE in 1 CARTON (65162-039-03) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE November 1, 2018
65162-039-06 65162-039 Amneal Pharmaceuticals LLC 1 BOTTLE in 1 CARTON (65162-039-06) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE November 1, 2018
65162-039-17 65162-039 Amneal Pharmaceuticals LLC 2 BLISTER PACK in 1 CARTON (65162-039-17) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK November 1, 2018
59651-068-15 59651-068 Aurobindo Pharma Limited 1500 TABLET, EXTENDED RELEASE in 1 BAG (59651-068-15) March 17, 2017
59651-069-82 59651-069 Aurobindo Pharma Limited 800 TABLET, EXTENDED RELEASE in 1 BAG (59651-069-82) March 17, 2017
58602-714-05 58602-714 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-714-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-714-07 58602-714 Aurohealth LLC 6 BLISTER PACK in 1 CARTON (58602-714-07) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03) March 17, 2017
58602-714-08 58602-714 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-714-08) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03) March 17, 2017
58602-714-09 58602-714 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-714-09) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-714-12 58602-714 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-714-12) / 40 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-714-15 58602-714 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-714-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-714-66 58602-714 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-714-66) / 58 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-714-67 58602-714 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-714-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (58602-714-03) March 17, 2017
58602-714-73 58602-714 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-714-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-715-05 58602-715 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-715-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-715-06 58602-715 Aurohealth LLC 6 BLISTER PACK in 1 CARTON (58602-715-06) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
58602-715-09 58602-715 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-715-09) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-715-10 58602-715 Aurohealth LLC 6 BLISTER PACK in 1 CARTON (58602-715-10) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
58602-715-15 58602-715 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-715-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-715-57 58602-715 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-715-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-715-60 58602-715 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-715-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-715-64 58602-715 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-715-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
58602-715-65 58602-715 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-715-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
58602-715-68 58602-715 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-715-68) / 38 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-715-69 58602-715 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-715-69) / 44 TABLET, EXTENDED RELEASE in 1 BOTTLE March 17, 2017
58602-715-70 58602-715 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-715-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
58602-824-08 58602-824 Aurohealth LLC 4 BLISTER PACK in 1 CARTON (58602-824-08) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
58602-824-67 58602-824 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-824-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
58602-825-06 58602-825 Aurohealth LLC 6 BLISTER PACK in 1 CARTON (58602-825-06) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
58602-825-65 58602-825 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-825-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK March 17, 2017
58602-849-11 58602-849 Aurohealth LLC 8 BLISTER PACK in 1 CARTON (58602-849-11) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 13, 2020
58602-849-15 58602-849 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-849-15) / 60 TABLET, EXTENDED RELEASE in 1 BOTTLE August 13, 2020
58602-849-57 58602-849 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-849-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE September 8, 2020
58602-849-64 58602-849 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-849-64) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK February 24, 2021
58602-849-65 58602-849 Aurohealth LLC 2 BLISTER PACK in 1 CARTON (58602-849-65) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK May 16, 2020
58602-871-83 58602-871 Aurohealth LLC 1 BLISTER PACK in 1 CARTON (58602-871-83) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK February 24, 2021
51316-009-01 51316-009 CVS Pharmacy 5 BLISTER PACK in 1 CARTON (51316-009-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 15, 2023
43598-114-01 43598-114 Dr. Reddy's Laboratories Inc. 5 BLISTER PACK in 1 CARTON (43598-114-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 15, 2023
43598-114-10 43598-114 Dr. Reddy's Laboratories Inc. 1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-114-10) September 13, 2023
43598-114-20 43598-114 Dr. Reddy's Laboratories Inc. 1 BLISTER PACK in 1 CARTON (43598-114-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 15, 2023
43598-114-40 43598-114 Dr. Reddy's Laboratories Inc. 2 BLISTER PACK in 1 CARTON (43598-114-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 15, 2023
43598-115-10 43598-115 Dr. Reddy's Laboratories Inc. 1000 TABLET, EXTENDED RELEASE in 1 POUCH (43598-115-10) September 13, 2023
43598-115-28 43598-115 Dr. Reddy's Laboratories Inc. 4 BLISTER PACK in 1 CARTON (43598-115-28) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 15, 2023
43598-115-32 43598-115 Dr. Reddy's Laboratories Inc. 2 BLISTER PACK in 1 CARTON (43598-115-32) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 15, 2023
43598-115-37 43598-115 Dr. Reddy's Laboratories Inc. 3 BLISTER PACK in 1 CARTON (43598-115-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-115-74) August 15, 2023
43598-115-42 43598-115 Dr. Reddy's Laboratories Inc. 6 BLISTER PACK in 1 CARTON (43598-115-42) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 15, 2023
43598-115-56 43598-115 Dr. Reddy's Laboratories Inc. 4 BLISTER PACK in 1 CARTON (43598-115-56) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-115-74) May 30, 2024
43598-115-70 43598-115 Dr. Reddy's Laboratories Inc. 1 BLISTER PACK in 1 CARTON (43598-115-70) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 15, 2023
43598-231-01 43598-231 Dr. Reddy's Laboratories Inc. 5 BLISTER PACK in 1 CARTON (43598-231-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK November 23, 2023
43598-232-37 43598-232 Dr. Reddy's Laboratories Inc. 3 BLISTER PACK in 1 CARTON (43598-232-37) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK December 1, 2023
30142-275-05 30142-275 KROGER COMPANY 4 BLISTER PACK in 1 CARTON (30142-275-05) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK May 21, 2024
30142-275-14 30142-275 KROGER COMPANY 2 BLISTER PACK in 1 CARTON (30142-275-14) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK May 21, 2024
30142-276-20 30142-276 KROGER COMPANY 2 BLISTER PACK in 1 CARTON (30142-276-20) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK May 27, 2024
30142-276-40 30142-276 KROGER COMPANY 4 BLISTER PACK in 1 CARTON (30142-276-40) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK May 27, 2024
30142-948-20 30142-948 Kroger Company 1 BLISTER PACK in 1 CARTON (30142-948-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK May 23, 2022
30142-948-40 30142-948 Kroger Company 2 BLISTER PACK in 1 CARTON (30142-948-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK May 23, 2022
30142-963-14 30142-963 Kroger Company 1 BLISTER PACK in 1 CARTON (30142-963-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK May 23, 2022
30142-963-28 30142-963 Kroger Company 2 BLISTER PACK in 1 CARTON (30142-963-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK May 23, 2022
51660-110-54 51660-110 OHM LABORATORIES INC 1 BLISTER PACK in 1 CARTON (51660-110-54) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 1, 2021
51660-110-58 51660-110 OHM LABORATORIES INC 3 BLISTER PACK in 1 CARTON (51660-110-58) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK June 5, 2026
51660-110-86 51660-110 OHM LABORATORIES INC 2 BLISTER PACK in 1 CARTON (51660-110-86) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 1, 2021
51660-301-21 51660-301 OHM LABORATORIES INC 1 BLISTER PACK in 1 CARTON (51660-301-21) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 1, 2021
51660-301-41 51660-301 OHM LABORATORIES INC 2 BLISTER PACK in 1 CARTON (51660-301-41) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 1, 2021
51660-301-61 51660-301 OHM LABORATORIES INC 3 BLISTER PACK in 1 CARTON (51660-301-61) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK June 5, 2026
41415-998-20 41415-998 PUBLIX SUPER MARKETS, INC 1 BLISTER PACK in 1 CARTON (41415-998-20) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 1, 2021
41415-999-14 41415-999 PUBLIX SUPER MARKETS, INC 1 BLISTER PACK in 1 CARTON (41415-999-14) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 1, 2021
63304-106-21 63304-106 SUN PHARMACEUTICAL INDUSTRIES, INC. 1 BLISTER PACK in 1 CARTON (63304-106-21) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 1, 2021
63304-110-54 63304-110 SUN PHARMACEUTICAL INDUSTRIES, INC. 1 BLISTER PACK in 1 CARTON (63304-110-54) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 1, 2021
85766-046-28 85766-046 Sportpharm LLC 4 BLISTER PACK in 1 CARTON (85766-046-28) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK August 2, 2025
85766-150-14 85766-150 Sportpharm LLC 1 BOTTLE in 1 CARTON (85766-150-14) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE February 19, 2026
76162-032-56 76162-032 TOPCO ASSOCIATES LLC 8 BLISTER PACK in 1 CARTON (76162-032-56) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK April 23, 2026
11673-267-05 11673-267 Target Corporation 1 BOTTLE in 1 CARTON (11673-267-05) / 14 TABLET, EXTENDED RELEASE in 1 BOTTLE July 4, 2024
11673-267-57 11673-267 Target Corporation 1 BOTTLE in 1 CARTON (11673-267-57) / 28 TABLET, EXTENDED RELEASE in 1 BOTTLE July 4, 2024
11673-267-60 11673-267 Target Corporation 1 BOTTLE in 1 CARTON (11673-267-60) / 42 TABLET, EXTENDED RELEASE in 1 BOTTLE July 4, 2024
71179-011-21 71179-011 VESPYR BRANDS LLC 3 BLISTER PACK in 1 CARTON (71179-011-21) / 7 TABLET, EXTENDED RELEASE in 1 BLISTER PACK July 14, 2022
52493-038 52493-038 Amneal Pharmaceuticals Co. (I) Pvt. Ltd. — July 3, 2024
52493-039 52493-039 Amneal Pharmaceuticals Co. (I) Pvt. Ltd. — July 3, 2024
65162-038 65162-038 Amneal Pharmaceuticals LLC — November 1, 2018
65162-039 65162-039 Amneal Pharmaceuticals LLC — November 1, 2018
59651-068 59651-068 Aurobindo Pharma Limited — March 17, 2017
59651-069 59651-069 Aurobindo Pharma Limited — March 17, 2017
58602-714 58602-714 Aurohealth LLC — March 17, 2017
58602-715 58602-715 Aurohealth LLC — March 17, 2017
58602-824 58602-824 Aurohealth LLC — March 17, 2017
58602-825 58602-825 Aurohealth LLC — March 17, 2017
58602-849 58602-849 Aurohealth LLC — May 16, 2020
58602-871 58602-871 Aurohealth LLC — February 24, 2021
51316-009 51316-009 CVS Pharmacy — August 15, 2023
43598-114 43598-114 Dr. Reddy's Laboratories Inc. — August 15, 2023
43598-115 43598-115 Dr. Reddy's Laboratories Inc. — August 15, 2023
43598-231 43598-231 Dr. Reddy's Laboratories Inc. — August 15, 2023
43598-232 43598-232 Dr. Reddy's Laboratories Inc. — August 15, 2023
30142-275 30142-275 KROGER COMPANY — May 21, 2024
30142-276 30142-276 KROGER COMPANY — May 27, 2024
30142-948 30142-948 Kroger Company — May 23, 2022
30142-963 30142-963 Kroger Company — May 23, 2022
51660-110 51660-110 OHM LABORATORIES INC — July 1, 2021
51660-301 51660-301 OHM LABORATORIES INC — July 1, 2021
41415-998 41415-998 PUBLIX SUPER MARKETS, INC — July 1, 2021
41415-999 41415-999 PUBLIX SUPER MARKETS, INC — July 1, 2021
63304-106 63304-106 SUN PHARMACEUTICAL INDUSTRIES, INC. — July 1, 2021
63304-110 63304-110 SUN PHARMACEUTICAL INDUSTRIES, INC. — July 1, 2021
85766-046 85766-046 Sportpharm LLC — March 17, 2017
85766-150 85766-150 Sportpharm LLC — March 17, 2017
76162-032 76162-032 TOPCO ASSOCIATES LLC — April 23, 2026
11673-267 11673-267 Target Corporation — July 4, 2024
71179-011 71179-011 VESPYR BRANDS LLC — July 14, 2022

Sources for this page

Every dataset that contributed a fact to 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.