NDC 35916-0189-01 - Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
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
- 35916-0189
- Requested NDC
- 35916-0189-01
- Package NDCs from labels
- 35916-0189-1, 35916-0189-01
- Manufacturer
- SOFTGEL HEALTHCARE PRIVATE LIMITED
- Effective date
- 2026-01-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| FD&C BLUE NO. 1 - SOFTGEL HEALTHCARE PRIVATE LIMITED | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2026-01-27 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-0189-1 | Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 35916-0189 | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PRIVATE LIMITED] | 1 | Current NDC, 1 package rows | 20250409_2f7f078e-de04-9d53-e063-6394a90a409f.zip |
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 |
|---|---|---|---|---|---|---|
| Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | cb475e7f-aec1-415d-9770-07cce4e02c07 | 2026-06-24 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | ef2c1fe2-75dd-43cf-871d-540c5e36d363 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Sagent Pharmaceuticals | 621282f6-75b3-401b-8e1a-c5153a0c9ecd | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | Bryant Ranch Prepack | fcb09a57-76d8-413c-801b-8d8ea0c3f1db | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Acetaminophen Regular Strength | ACETAMINOPHEN | CVS PHARMACY | 5e35df92-6282-4ca6-902b-bb6bd326b487 | 2026-06-23 | Warnings | 362O9ITL9D |
| Broncolito Children | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Pharmadel LLC | 509f5b72-9894-ef44-e063-6394a90a6d07 | 2026-06-23 | Warnings | M012 9D2RTI9KYH |
| Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | L'Oreal USA Products Inc | 54ecaea7-dafe-9694-e063-6394a90ae3b5 | 2026-06-23 | Warnings | 15FIX9V2JP |
| Neo-Synephrine Severe | PHENYLEPHRINE HYDROCHLORIDE | BF ASCHER AND CO INC | 54edaff7-d241-dc90-e063-6294a90ac64d | 2026-06-23 | Warnings | M012 |
| AXIV Sinus Severe Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE. | VIVUNT PHARMA LLC | 4b81abf9-3ea7-e996-e063-6394a90a71e8 | 2026-06-23 | Warnings | M012 |
| AXIV Sinus OVERNIGHT | OXYMETAZOLINE HYDROCHLORIDE. | VIVUNT PHARMA LLC | 54e03a63-f978-33d4-e063-6394a90a30f2 | 2026-06-23 | Warnings | M012 |
| Bacteriostatic Water | BACTERIOSTATIC WATER | Fujian Genohope Biotech Ltd. | 54f66b82-c9e5-a2bc-e063-6394a90adbbc | 2026-06-23 | 059QF0KO0R | |
| equaline daytime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 9a199782-5d7e-449b-a86c-969746f0e96f | 2026-06-23 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Walgreen Company | 542b9861-8055-45f6-8cbf-9fe5cde1c4d9 | 2026-06-23 | Warnings | M012 9D2RTI9KYH |
| Pain Reliever | ACETAMINOPHEN | Orelli Inc. | 4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d | 2026-06-22 | Warnings | 362O9ITL9D |
| RYDEEN UV CLEAR | SUNSCREEN | Guangzhou Oupeng Cosmetics Co., Ltd. | 548000cd-1655-aeb3-e063-6294a90ad004 | 2026-06-22 | Warnings | 15FIX9V2JP |
| Allergy Relief | DIPHENHYDRAMINE HCL | BIONPHARMA INC. | 3c1953a1-32e9-6c81-e063-6294a90a9fa2 | 2026-06-22 | Warnings | M012 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Dr. Reddy's Labratories Inc. | 79be4527-73b4-93b2-5858-1e2a9819fd50 | 2026-06-22 | Warnings, Adverse reactions | 9D2RTI9KYH |
| DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 59db2573-7ebb-4cf9-bfe3-428929bb4eeb | 2026-06-22 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Best Choice (Valu Merchandisers Company) | bfec14d5-d9ce-4b9c-a803-3d01cb00b56c | 2026-06-22 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | WinCo Foods, LLC | 5f1aaa8e-c65f-43b3-9850-c60c1663d78f | 2026-06-22 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.