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 |
|---|---|---|---|---|---|---|
| CVS Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | CVS PHARMACY | 558b7ed6-a9f6-452c-90cd-df8258663bf1 | 2026-08-18 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Rugby Laboratories | 76f10ee2-1d6a-097c-e053-2991aa0af526 | 2026-08-18 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Major Pharmaceuticals | 780aad35-d0f1-44b1-e053-2991aa0af9a7 | 2026-08-18 | Warnings | 362O9ITL9D |
| Rohto Preservative Free Dry Aid | POVIDONE, PROPYLENE GLYCOL | The Mentholatum Company | f4b1974c-2412-45f6-b79d-88b8a0bcb608 | 2026-08-18 | Warnings | FZ989GH94E |
| Rohto Dry-Aid | POVIDONE, PROPYLENE GLYCOL | The Mentholatum Company | 8ea5c6c9-48f4-406a-a2cb-9280c546d87d | 2026-08-18 | Warnings | FZ989GH94E |
| CHILDRENS PAIN AND FEVER | ACETAMINOPHEN | Amazon.com Services LLC | 5eacbc4f-d20a-4c22-9680-4a648e24de43 | 2026-08-18 | Warnings | 362O9ITL9D |
| CVS Overnight Cold and Flu Clear and Cool | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | CVS PHARMACY, INC | 2497a011-d7a0-4d69-97e2-bbf25a99b1cc | 2026-08-17 | Warnings | 362O9ITL9D |
| Mucus Relief Cough Cold Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | 3ef949f5-ac8c-44be-b04d-6996fa59a94b | 2026-08-17 | Warnings | 362O9ITL9D |
| Sinus PE Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 28a4ec37-11dd-4134-81aa-851f081bf088 | 2026-08-17 | Warnings | 362O9ITL9D |
| CVS Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | CVS HEALTH | f01ab8ef-d29a-4e33-8a14-4c57ccdcc0d6 | 2026-08-17 | Warnings | 362O9ITL9D |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 77f87e19-a9d5-479d-9434-bbde13210bfb | 2026-08-15 | Warnings | 362O9ITL9D |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. DBA Leader | b1c2055b-4b5a-4fa2-b600-8930c9c8524c | 2026-08-15 | Warnings | 362O9ITL9D |
| Nighttime HBP Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS PHARMACY | 146c9a62-0418-4b5d-9074-5be8a05f3f93 | 2026-08-15 | Warnings | 362O9ITL9D |
| Pain Relief Childrens | ACETAMINOPHEN | WinCo Foods, LLC | 15921c3f-e8d4-4794-983f-63bb926f6f86 | 2026-08-15 | Warnings | 362O9ITL9D |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 610accad-2f8b-4605-9357-a58e6e18d417 | 2026-08-15 | Warnings | 362O9ITL9D |
| Cold and Flu Night | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | 32c67914-d7cf-40ee-8682-0ba8ed691287 | 2026-08-15 | Warnings | 362O9ITL9D |
| Childrens Pain plus Fever Relief | ACETAMINOPHEN | CVS PHARMACY | e4cbfb06-d826-4d08-95d6-60305c417625 | 2026-08-14 | Warnings | 362O9ITL9D |
| CVS Childrens COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | CVS PHARMACY | 27820bce-6638-4f17-ac66-62b02b76bec3 | 2026-08-14 | Warnings | 362O9ITL9D |
| CVS Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN | CVS PHARMACY | 333e170e-52cd-4218-8d15-0bf3c5c75cb9 | 2026-08-14 | Warnings | 362O9ITL9D |
| CVS NightTime Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | 0f0cc40d-7939-4d4d-a931-b4de4070fea1 | 2026-08-14 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.