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Acetaminophen
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Acetaminophen | 650 mg/1 | 313782 | View |
Forms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 207229-001 | ACETAMINOPHEN | TABLET, EXTENDED RELEASE | ACETAMINOPHEN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 14 | Labeling | Approved | April 13, 2023 | Standard |
| Supplement | 13 | Labeling | Approved | April 13, 2023 | Standard |
| Supplement | 10 | Labeling | Approved | April 13, 2023 | Standard |
| Supplement | 9 | Labeling | Approved | April 13, 2023 | Standard |
| Original application | 1 | Approved | November 9, 2016 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260521). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUSES For Arthritis Pain label • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • premenstrual and menstrual cramps • the common cold • headache • toothache • temporarily reduces fever For Muscle Aches & Pain label • temporarily relieves minor aches and pains due to: • muscular aches • backache • minor pain of arthritis • toothache • premenstrual and menstrual cramps • headache • the common cold • temporarily reduces fever
Purpose
openFDA Drug LabelingPurpose Pain reliever/fever reducer
Dosage and Administration
openFDA Drug LabelingDIRECTIONS For Arthritis Pain Label • do not take more than directed (see overdose warning) adults • take 2 caplets every 8 hours with water • swallow whole; do not crush, chew, split or dissolve • do not take more than 6 caplets in 24 hours • do not use for more than 10 days unless directed by a doctor under 18 years of age • ask a doctor For Muscle Ache and Pain label • do not take more than directed (see overdose warning) adults and children 12 years of age and over • take 2 caplets every 8 hours with water • swallow whole; do not crush, chew, split or dissolve • do not take more than 6 caplets in 24 hours • do not use for more than 10 days unless directed by a doctor children under 12 years • do not use
Warnings
openFDA Drug LabelingWarnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 geltabs in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets. if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present the tablet got stuck in your throat These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do Not Use
openFDA Drug LabelingDo not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have liver disease.
Stop Use
openFDA Drug LabelingStop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use.
Active Ingredient
openFDA Drug LabelingDrug Facts Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Acetaminophen Extended-Release 650 mg Tablet NDC 71335-9746-1: 30 Tablets in a BOTTLE NDC 71335-9746-2: 100 Tablets in a BOTTLE NDC 71335-9746-3: 50 Tablets in a BOTTLE NDC 71335-9746-4: 60 Tablets in a BOTTLE NDC 71335-9746-5: 120 Tablets in a BOTTLE NDC 71335-9746-6: 19 Tablets in a BOTTLE NDC 71335-9746-7: 20 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ACETAMINOPHEN. 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 |
|---|---|---|---|---|
| 76420-914-01 | 76420-914 | Asclemed USA, Inc. | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-01) | January 27, 2025 |
| 76420-914-05 | 76420-914 | Asclemed USA, Inc. | 50 BOTTLE in 1 CARTON (76420-914-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE | January 27, 2025 |
| 76420-914-26 | 76420-914 | Asclemed USA, Inc. | 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-26) | January 25, 2025 |
| 76420-914-40 | 76420-914 | Asclemed USA, Inc. | 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-40) | January 27, 2025 |
| 76420-914-42 | 76420-914 | Asclemed USA, Inc. | 1 BOTTLE in 1 CARTON (76420-914-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | January 27, 2025 |
| 76420-914-60 | 76420-914 | Asclemed USA, Inc. | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-60) | February 25, 2025 |
| 59651-034-15 | 59651-034 | Aurobindo Pharma Limited | 1500 TABLET, EXTENDED RELEASE in 1 BAG (59651-034-15) | November 9, 2016 |
| 59651-034-39 | 59651-034 | Aurobindo Pharma Limited | 35000 TABLET, EXTENDED RELEASE in 1 BAG (59651-034-39) | November 18, 2022 |
| 58602-730-07 | 58602-730 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-730-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | August 11, 2018 |
| 58602-730-14 | 58602-730 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-730-14) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE | August 11, 2018 |
| 58602-730-21 | 58602-730 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-730-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE | August 11, 2018 |
| 58602-730-28 | 58602-730 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-730-28) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE | December 29, 2021 |
| 58602-730-29 | 58602-730 | Aurohealth LLC | 150 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-29) | August 11, 2018 |
| 58602-730-34 | 58602-730 | Aurohealth LLC | 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-34) | August 11, 2018 |
| 58602-730-35 | 58602-730 | Aurohealth LLC | 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-35) | August 11, 2018 |
| 58602-730-36 | 58602-730 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-730-36) / 250 TABLET, EXTENDED RELEASE in 1 BOTTLE | November 9, 2016 |
| 58602-730-40 | 58602-730 | Aurohealth LLC | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-40) | August 11, 2018 |
| 58602-730-41 | 58602-730 | Aurohealth LLC | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-41) | August 11, 2018 |
| 58602-730-44 | 58602-730 | Aurohealth LLC | 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-44) | January 11, 2021 |
| 58602-730-67 | 58602-730 | Aurohealth LLC | 290 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-67) | August 11, 2018 |
| 58602-730-76 | 58602-730 | Aurohealth LLC | 325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-76) | August 11, 2018 |
| 58602-730-94 | 58602-730 | Aurohealth LLC | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-94) | April 8, 2020 |
| 58602-848-17 | 58602-848 | Aurohealth LLC | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-17) | May 21, 2026 |
| 58602-848-40 | 58602-848 | Aurohealth LLC | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-40) | May 21, 2026 |
| 58602-848-44 | 58602-848 | Aurohealth LLC | 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-44) | May 21, 2026 |
| 58602-873-07 | 58602-873 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-873-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | December 27, 2021 |
| 58602-873-14 | 58602-873 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-873-14) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE | December 27, 2021 |
| 58602-873-21 | 58602-873 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-873-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE | December 27, 2021 |
| 58602-873-29 | 58602-873 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-873-29) / 150 TABLET, EXTENDED RELEASE in 1 BOTTLE | December 27, 2021 |
| 58602-873-34 | 58602-873 | Aurohealth LLC | 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-34) | December 27, 2021 |
| 58602-873-35 | 58602-873 | Aurohealth LLC | 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-35) | December 27, 2021 |
| 58602-873-36 | 58602-873 | Aurohealth LLC | 1 BOTTLE in 1 CARTON (58602-873-36) / 250 TABLET, EXTENDED RELEASE in 1 BOTTLE | December 27, 2021 |
| 58602-873-40 | 58602-873 | Aurohealth LLC | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-40) | December 27, 2021 |
| 58602-873-41 | 58602-873 | Aurohealth LLC | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-41) | December 27, 2021 |
| 58602-873-44 | 58602-873 | Aurohealth LLC | 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-44) | December 27, 2021 |
| 58602-873-67 | 58602-873 | Aurohealth LLC | 290 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-67) | December 27, 2021 |
| 58602-873-76 | 58602-873 | Aurohealth LLC | 325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-76) | December 27, 2021 |
| 58602-873-94 | 58602-873 | Aurohealth LLC | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-94) | December 27, 2021 |
| 21130-108-07 | 21130-108 | Better Living Brands, LLC | 1 BOTTLE in 1 CARTON (21130-108-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | June 24, 2022 |
| 21130-108-35 | 21130-108 | Better Living Brands, LLC | 1 BOTTLE in 1 CARTON (21130-108-35) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE | June 24, 2022 |
| 37835-512-01 | 37835-512 | Bi-Mart | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (37835-512-01) | March 1, 2025 |
| 71335-1340-1 | 71335-1340 | Bryant Ranch Prepack | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-1) | December 4, 2019 |
| 71335-1340-2 | 71335-1340 | Bryant Ranch Prepack | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-2) | August 20, 2019 |
| 71335-1340-3 | 71335-1340 | Bryant Ranch Prepack | 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-3) | October 7, 2024 |
| 71335-1340-4 | 71335-1340 | Bryant Ranch Prepack | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-4) | October 7, 2024 |
| 71335-1340-5 | 71335-1340 | Bryant Ranch Prepack | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-5) | July 23, 2024 |
| 71335-1340-6 | 71335-1340 | Bryant Ranch Prepack | 19 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-6) | October 7, 2024 |
| 71335-1340-7 | 71335-1340 | Bryant Ranch Prepack | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-7) | October 7, 2024 |
| 71335-9746-1 | 71335-9746 | Bryant Ranch Prepack | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-1) | November 16, 2023 |
| 71335-9746-2 | 71335-9746 | Bryant Ranch Prepack | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-2) | April 5, 2024 |
| 71335-9746-3 | 71335-9746 | Bryant Ranch Prepack | 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-3) | April 5, 2024 |
| 71335-9746-4 | 71335-9746 | Bryant Ranch Prepack | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-4) | April 5, 2024 |
| 71335-9746-5 | 71335-9746 | Bryant Ranch Prepack | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-5) | April 5, 2024 |
| 71335-9746-6 | 71335-9746 | Bryant Ranch Prepack | 19 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-6) | April 5, 2024 |
| 71335-9746-7 | 71335-9746 | Bryant Ranch Prepack | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-7) | April 5, 2024 |
| 63868-660-01 | 63868-660 | CHAIN DRUG MARKETING ASSOCIATION INC | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63868-660-01) | August 1, 2020 |
| 63868-660-50 | 63868-660 | CHAIN DRUG MARKETING ASSOCIATION INC | 1 BOTTLE, PLASTIC in 1 PACKAGE (63868-660-50) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC | August 1, 2020 |
| 69842-930-80 | 69842-930 | CVS Pharmacy | 80 TABLET, EXTENDED RELEASE in 1 BOTTLE (69842-930-80) | December 21, 2012 |
| 69842-037-35 | 69842-037 | CVS Pharmacy, Inc. | 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (69842-037-35) | December 23, 2020 |
| 69842-037-44 | 69842-037 | CVS Pharmacy, Inc. | 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (69842-037-44) | December 23, 2020 |
| 69842-635-07 | 69842-635 | CVS Pharmacy, Inc. | 1 BOTTLE in 1 CARTON (69842-635-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | October 13, 2022 |
| 57896-268-01 | 57896-268 | GERI-CARE PHARMACEUTICAL CORP | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (57896-268-01) | July 1, 2019 |
| 62207-183-34 | 62207-183 | Granules India Limited | 1 POUCH in 1 BOX (62207-183-34) / 5 TABLET, EXTENDED RELEASE in 1 POUCH | June 30, 2019 |
| 62207-183-35 | 62207-183 | Granules India Limited | 6 POUCH in 1 BOX (62207-183-35) / 3000 TABLET, EXTENDED RELEASE in 1 POUCH | May 4, 2024 |
| 62207-183-49 | 62207-183 | Granules India Limited | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-183-49) | April 18, 2019 |
| 62207-183-51 | 62207-183 | Granules India Limited | 1 BOTTLE in 1 CARTON (62207-183-51) / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE | April 18, 2019 |
| 62207-183-87 | 62207-183 | Granules India Limited | 1 POUCH in 1 BOX (62207-183-87) / 1 TABLET, EXTENDED RELEASE in 1 POUCH | June 30, 2019 |
| 62207-183-97 | 62207-183 | Granules India Limited | 40000 TABLET, EXTENDED RELEASE in 1 DRUM (62207-183-97) | March 25, 2021 |
| 62207-188-49 | 62207-188 | Granules India Limited | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-188-49) | April 18, 2019 |
| 62207-188-51 | 62207-188 | Granules India Limited | 1 BOTTLE in 1 CARTON (62207-188-51) / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE | April 18, 2019 |
| 62207-234-35 | 62207-234 | Granules India Limited | 18000 TABLET, EXTENDED RELEASE in 1 BOX (62207-234-35) | January 1, 2025 |
| 62207-892-49 | 62207-892 | Granules India Limited | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-892-49) | April 16, 2026 |
| 62207-892-51 | 62207-892 | Granules India Limited | 1 BOTTLE in 1 CARTON (62207-892-51) / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE | April 16, 2026 |
| 70010-160-01 | 70010-160 | Granules Pharmaceuticals Inc. | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-160-01) | February 15, 2022 |
| 30142-157-07 | 30142-157 | KROGER COMPANY | 1 BOTTLE in 1 CARTON (30142-157-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | May 25, 2021 |
| 30142-157-35 | 30142-157 | KROGER COMPANY | 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (30142-157-35) | May 25, 2021 |
| 0615-8624-39 | 0615-8624 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8624-39) | February 10, 2026 |
| 49483-699-01 | 49483-699 | TIME CAP LABORATORIES, INC. | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-01) | October 4, 2021 |
| 49483-699-05 | 49483-699 | TIME CAP LABORATORIES, INC. | 50 BOTTLE in 1 CARTON (49483-699-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE | October 4, 2021 |
| 49483-699-26 | 49483-699 | TIME CAP LABORATORIES, INC. | 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-26) | November 7, 2022 |
| 49483-699-40 | 49483-699 | TIME CAP LABORATORIES, INC. | 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-40) | October 4, 2021 |
| 49483-699-42 | 49483-699 | TIME CAP LABORATORIES, INC. | 1 BOTTLE in 1 CARTON (49483-699-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | November 7, 2022 |
| 0363-9604-07 | 0363-9604 | WALGREEN CO. | 1 BOTTLE in 1 CARTON (0363-9604-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | July 7, 2021 |
| 0363-9604-35 | 0363-9604 | WALGREEN CO. | 1 BOTTLE in 1 CARTON (0363-9604-35) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE | July 7, 2021 |
| 79903-132-25 | 79903-132 | WALMART INC. | 325 TABLET, EXTENDED RELEASE in 1 BOTTLE (79903-132-25) | July 26, 2022 |
| 0363-0340-08 | 0363-0340 | Walgreen Company | 80 TABLET, EXTENDED RELEASE in 1 BOTTLE (0363-0340-08) | May 1, 2016 |
| 76420-914 | 76420-914 | Asclemed USA, Inc. | — | October 4, 2021 |
| 59651-034 | 59651-034 | Aurobindo Pharma Limited | — | November 9, 2016 |
| 58602-730 | 58602-730 | Aurohealth LLC | — | November 9, 2016 |
| 58602-848 | 58602-848 | Aurohealth LLC | — | May 16, 2020 |
| 58602-873 | 58602-873 | Aurohealth LLC | — | December 27, 2021 |
| 21130-108 | 21130-108 | Better Living Brands, LLC | — | June 24, 2022 |
| 37835-512 | 37835-512 | Bi-Mart | — | April 18, 2019 |
| 71335-1340 | 71335-1340 | Bryant Ranch Prepack | — | July 1, 2019 |
| 71335-9746 | 71335-9746 | Bryant Ranch Prepack | — | October 4, 2021 |
| 63868-660 | 63868-660 | CHAIN DRUG MARKETING ASSOCIATION INC | — | August 1, 2020 |
| 69842-930 | 69842-930 | CVS Pharmacy | — | December 21, 2012 |
| 69842-037 | 69842-037 | CVS Pharmacy, Inc. | — | December 23, 2020 |
| 69842-635 | 69842-635 | CVS Pharmacy, Inc. | — | October 13, 2022 |
| 57896-268 | 57896-268 | GERI-CARE PHARMACEUTICAL CORP | — | July 1, 2019 |
| 62207-183 | 62207-183 | Granules India Limited | — | April 18, 2019 |
| 62207-188 | 62207-188 | Granules India Limited | — | April 18, 2019 |
| 62207-234 | 62207-234 | Granules India Limited | — | January 1, 2025 |
| 62207-892 | 62207-892 | Granules India Limited | — | April 16, 2026 |
| 70010-160 | 70010-160 | Granules Pharmaceuticals Inc. | — | February 15, 2022 |
| 30142-157 | 30142-157 | KROGER COMPANY | — | May 25, 2021 |
| 0615-8624 | 0615-8624 | NCS HealthCare of KY, LLC dba Vangard Labs | — | February 15, 2022 |
| 49483-699 | 49483-699 | TIME CAP LABORATORIES, INC. | — | October 4, 2021 |
| 0363-9604 | 0363-9604 | WALGREEN CO. | — | July 7, 2021 |
| 79903-132 | 79903-132 | WALMART INC. | — | July 26, 2022 |
| 0363-0340 | 0363-0340 | Walgreen Company | — | May 1, 2016 |
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.