NDC 00591-0385 - HYDROCODONE BITARTRATE AND ACETAMINOPHEN
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 00591-0385
- Manufacturer
- Keltman Pharmaceuticals Inc.
- Effective date
- 2010-12-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| hydrocodone bitartrate and acetaminophen tablet | Keltman Pharmaceuticals Inc. | 2010-12-10 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Socrata Ingredients#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Lupin Pharmaceuticals,Inc. | 48cc1378-ffab-4645-95bb-a05d78066575 | 2024-02-15 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Extra Strength Pain Reliever | ACETAMINOPHEN | INGLES MARKETS, INC. | 115d0b4f-6f0f-79a9-e063-6394a90ab18a | 2024-02-14 | Warnings | 362O9ITL9D |
| Allergy Sinus, Lil Drug Store | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE | Lil' Drug Store Products, Inc. | 1145440e-b37a-6e5e-e063-6294a90ab4a0 | 2024-02-13 | Warnings | 362O9ITL9D |
| Theraflu ExpressMax Daytime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | ff48b55a-0d32-47d6-941d-d99c7cf52f94 | 2024-02-12 | Warnings | 362O9ITL9D |
| OXYCODONE AND ACETAMINOPHEN | OXYCODONE AND ACETAMINOPHEN | XLCare Pharmaceuticals, Inc. | 7f3c6dd7-6bc8-450e-aded-997f9cf63a8f | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| PANADOL | ACETAMINOPHEN | Haleon US Holdings LLC | e1799765-c247-42b4-ad6a-8ba7d136abf2 | 2024-02-06 | Warnings | 362O9ITL9D |
| Panadol Cold and Flu NonDrowsy | ACETAMINOPHEN AND PHENYLEPRINE HCL | Haleon US Holdings LLC | f626ab17-01c9-4493-ba9e-0c8c11146384 | 2024-02-06 | Warnings | 362O9ITL9D |
| PANADOL Extra | ACETAMINOPHEN AND CAFFEINE | Haleon US Holdings LLC | e5c2d88a-d903-4ca0-b895-f27e791dfc4e | 2024-02-06 | Warnings | 362O9ITL9D |
| PANADOL Extra Strength | ACETAMINOPHEN | Haleon US Holdings LLC | b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b | 2024-02-06 | Warnings | 362O9ITL9D |
| PANADOL Extra Strength | ACETAMINOPHEN | Haleon US Holdings LLC | 9d384e88-5c11-4600-ac6c-a38371570138 | 2024-02-06 | Warnings | 362O9ITL9D |
| PANADOL | ACETAMINOPHEN | Haleon US Holdings LLC | 95801755-db54-4ad7-bec1-52671914f6ca | 2024-02-06 | Warnings | 362O9ITL9D |
| PANADOL PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 01e7dddb-755c-4745-b701-edcdb6209064 | 2024-02-06 | Warnings, Adverse reactions | 362O9ITL9D |
| PANADOL PM | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | fe7cd1f2-9b00-4ded-99c2-8a152c71093c | 2024-02-06 | Warnings, Adverse reactions | 362O9ITL9D |
| Topcare Dual Action Back Pain | ACETAMINOPHEN, IBUPROFEN | Topco Associates LLC | e40ec21c-6c44-4219-a94f-8b93a4853aa5 | 2024-02-06 | Warnings | 362O9ITL9D |
| Butal/APAP/Caff | BUTAL/APAP/CAFF | Direct_Rx | f6dc9bbc-3331-b422-e053-6394a90af9a1 | 2024-02-05 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| THERAFLU Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 7d902237-a990-4c5e-875b-291e124e143b | 2024-02-03 | Warnings | 362O9ITL9D |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 4daca846-8511-4303-9e6c-9469f7f260ba | 2024-02-02 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Lupin Pharmaceuticals,Inc. | 26a2178e-e0e5-4d61-81fd-e30a3142f1f2 | 2024-02-02 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Childrens Pain and Fever | ACETAMINOPHEN | AptaPharma Inc. | 9064943f-836f-4853-b6f2-2c4879941eeb | 2024-02-02 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu ReadyInCase | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | P & L Development, LLC | 155a7168-b568-41f4-b8a2-214889b4eccf | 2024-02-02 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.