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 |
|---|---|---|---|---|---|---|
| Midol Complete | ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE | Acme United Corporation | f7bf126d-a6f1-231a-e053-6294a90a04e1 | 2024-11-07 | Warnings | 362O9ITL9D |
| Leader Daytime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Cardinal Health 110, LLC. dba Leader | dd82a389-9ec5-4b3f-a9ea-1a56871ebd17 | 2024-11-07 | Warnings | 362O9ITL9D |
| topcare day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | 1a8e2e03-e11b-4da1-945b-e2caadea7243 | 2024-11-07 | Warnings | 362O9ITL9D |
| good sense severe day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 44130a1b-63cc-42ac-9590-fdf21a12d164 | 2024-11-07 | Warnings | 362O9ITL9D |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | a5ff1134-8985-4585-8e61-a5fd5f60afeb | 2024-11-07 | Warnings | 362O9ITL9D |
| CareOne Childrens Acetaminophen | ACETAMINOPHEN | American Sales Company | 49021ae8-9655-4885-9f74-52df4cdcb26f | 2024-11-07 | Warnings | 362O9ITL9D |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 50528d29-ce8c-4efb-a86c-17246b017db0 | 2024-11-07 | Warnings | 362O9ITL9D |
| cooling severe daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS Pharmacy | d4a21760-b2bd-4e26-bff0-6fc1b05d26b3 | 2024-11-07 | Warnings | 362O9ITL9D |
| dg health day time severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, LLC | 60870311-3234-44ba-95dd-09cf4ea3d508 | 2024-11-07 | Warnings | 362O9ITL9D |
| foster and thrive pain reliever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 338021bd-b92b-45eb-a4b8-bc4a100ab718 | 2024-11-06 | Warnings | 362O9ITL9D |
| basic care headache relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Amazon.com Services LLC | f85d2f4c-8184-4555-a310-3979722e860b | 2024-11-05 | Warnings | 362O9ITL9D |
| MENSTRUAL COMPLETE | MENSTRUAL COMPLETE | Allegiant Health | d197b886-67e4-4aba-8582-305576c07604 | 2024-11-05 | Warnings | 362O9ITL9D |
| dg health headache relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Dolgencorp Inc | ddf40cc4-d73f-4460-be72-9486134329a7 | 2024-11-05 | Warnings | 362O9ITL9D |
| Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway, Inc. | 164b2559-2d3f-431e-a03c-07e86731af5c | 2024-11-04 | Warnings | 362O9ITL9D |
| tussin severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | 7cc2c136-d1b7-4658-99bb-73bb1d140261 | 2024-11-04 | Warnings | 362O9ITL9D |
| dg health tussin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | a5d0ee70-d528-4a53-bf01-7bb13b364ed0 | 2024-11-04 | Warnings | 362O9ITL9D |
| basic care tussin cf severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | bba9a17d-eb87-46f3-acee-c9dd34e5bfd4 | 2024-11-04 | Warnings | 362O9ITL9D |
| topcare tussin cf max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | b553b7e6-933b-49e3-97d3-22a4643a04b9 | 2024-11-04 | Warnings | 362O9ITL9D |
| DOLO- NeuroBion Acetaminophen 500mg | ACETAMINOPHEN | BENARD INDUSTRIES INC | 16f8415d-8190-4212-b487-c0caf7d3bee2 | 2024-11-04 | Warnings | 362O9ITL9D |
| basic care acetaminophen | ACETAMINOPHEN | Amazon.com Services LLC | 8c3343ee-d7b6-496d-9702-6736539a7270 | 2024-11-02 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.