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 |
|---|---|---|---|---|---|---|
| equate vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b2c0692c-ed0b-4fcf-b88d-59a788b124c6 | 2025-11-14 | Warnings | 362O9ITL9D |
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | NuCare Pharmaceuticals,Inc. | 437e4fd9-c7d9-77d6-e063-6294a90a22b7 | 2025-11-13 | Warnings | 362O9ITL9D |
| Theraflu Severe Cold Relief Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | c24b9489-208c-472b-8ae5-c6e86c12e04d | 2025-11-13 | Warnings | 362O9ITL9D |
| Theraflu Severe Cold Relief Chest Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | 8c821671-dc68-4e27-aa87-b4e45ade9817 | 2025-11-13 | Warnings | 362O9ITL9D |
| Robitussin Maximum Strength Severe Cough Plus Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 6a6f5da8-6433-4284-8df7-2d5b099b74dc | 2025-11-13 | Warnings | 362O9ITL9D |
| Cold and Flu DayTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Safeway, Inc. | 7a78f24b-7c23-4318-99dc-90c05db185b1 | 2025-11-13 | Warnings | 362O9ITL9D |
| equate vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | b6da1659-8c79-4cce-a817-907a7f061a2d | 2025-11-13 | Warnings | 362O9ITL9D |
| Good Sense Pain Relief | ACETAMINOPHEN | L. Perrigo Company | 7f78028a-484b-48b3-a37a-1e0b055bbefc | 2025-11-13 | Warnings | 362O9ITL9D |
| OneSsip Acetaminophen | ACETAMINOPHEN | MEDWISE LIFESCIENCES INC. | 3f88de0f-6cf6-3580-e063-6294a90abcb4 | 2025-11-12 | Warnings | 362O9ITL9D |
| TOPCARE Childrens Cold and Cough and Runny Nose | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates, LLC | 8931d4ca-c599-49be-87e1-8c0598f38b77 | 2025-11-11 | Warnings | 362O9ITL9D |
| Butalbital, Acetaminophen, and Caffeine | BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE | AvKARE | f5bbad36-6a0e-3518-3f12-138ae9f63980 | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b1a31-353d-af20-e063-6294a90aa907 | 2025-11-11 | Warnings | 362O9ITL9D |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 2025-11-11 | Warnings | 362O9ITL9D |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435e6387-1ee0-c20f-e063-6294a90adac5 | 2025-11-11 | Warnings | 362O9ITL9D |
| Good Neighbor Pharmacy Pain Relief | ACETAMINOPHEN | Amerisource Bergen | 4b829607-f5fb-427f-83b5-5b6b9c44ebeb | 2025-11-11 | Warnings | 362O9ITL9D |
| Buscapina | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | OPMX LLC | 10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b | 2025-11-10 | Warnings | 362O9ITL9D |
| Hydrocodone Bitartrate and Acetaminophen | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Asclemed USA, Inc. | d1de0f93-1439-4ee3-b692-56e1a1400682 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | NO70W886KK 362O9ITL9D |
| Pamprin Max Menstrual Pain Relief | ACETAMINOPHEN AND ASPIRIN AND CAFFEINE | Focus Consumer Healthcare, LLC | 5bd4b935-f003-7df8-e053-2a91aa0a5d79 | 2025-11-10 | Warnings | 362O9ITL9D |
| Leader 8HR Arthritis Pain Relief | ACETAMINOPHEN | Cardinal Health 110, LLC. dba Leader | 2b28e5aa-da4b-4fee-ad49-e5fd6f1c65f6 | 2025-11-10 | Warnings | 362O9ITL9D |
| good sense migraine formula | ACETAMINOPHEN, ASPIRIN, CAFFEINE | L. Perrigo Company | 93e7ba56-5682-4184-9a93-3b4b972b0e72 | 2025-11-10 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.