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, Nighttime, Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 5fe9f313-d6e7-41f5-abfc-e4c72b708961 | 2026-06-15 | Warnings | M012 |
| Pain Relief Sinus Congestion | ACETAMINOPHEN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 1d3d6397-0d92-4145-9a70-8bcc45bd0322 | 2026-06-15 | Warnings | M012 362O9ITL9D |
| RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM Caplet | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 2d63671d-cf7c-bbdd-e063-6294a90affef | 2026-06-15 | Warnings | 362O9ITL9D |
| Shield by HEALTHY SKIN LAB MD SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | HEALTHY SKIN LAB LIMITED | 6838b754-9915-48ff-af35-5338dbd06ac4 | 2026-06-15 | Warnings | 15FIX9V2JP |
| ACETAMINOPHEN | ACETAMINOPHEN | Granules India Limited | 00eb3e4b-1507-4c9a-83a5-ef50cb312753 | 2026-06-15 | Warnings | 362O9ITL9D |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 59773893-09a8-47a2-943a-e9ea9da4458a | 2026-06-15 | Warnings | 362O9ITL9D |
| Mucinex DM | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 70987d06-d206-445f-bd0d-5e1345b8465c | 2026-06-15 | Warnings | 9D2RTI9KYH |
| Pain Relief | ACETAMINOPHEN | Shield Pharmaceuticals Corp. | 96eb7f9f-ff2d-4661-bbe6-1860aafe03f6 | 2026-06-15 | Warnings | 362O9ITL9D |
| Duralgina Extra Strength | ACETAMINOPHEN | Menper Distributors, Inc. | 544e3d7e-a759-384f-e063-6294a90a5baa | 2026-06-15 | Warnings | 362O9ITL9D |
| WALGREEN GLYCERIN ADULT | GLYCERIN SUPPOSITORY | Walgreens | 20c44346-0b29-7364-e063-6294a90a648f | 2026-06-15 | Warnings | PDC6A3C0OX |
| WALGREENS GLYCERIN | GLYCERIN SUSPENSION | Walgreens | 20c44346-0b2b-7364-e063-6294a90a648f | 2026-06-15 | Warnings | PDC6A3C0OX |
| Goodmeds Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | c1cc40f4-9bbb-47f2-ba3b-a5c46ec10f11 | 2026-06-15 | Warnings | M012 |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | 3cd1cb17-4aea-a750-e063-6394a90a9594 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Oxycodone and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | 3cd2e535-dd11-4bfb-e063-6394a90a9fbc | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | 3d3292f0-93b5-1fd0-e063-6294a90a3716 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | d5d9334d-3db6-4f45-ab84-3e1ec5a752c6 | 2026-06-15 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Geiss, Destin & Dunn Inc. | fac64ddc-a89b-4d73-b9e5-edc4e5cc3c4b | 2026-06-15 | Warnings | M012 |
| Nighttime Sleep Aid | DOXYLAMINE SUCCINATE | Amerisource Bergen | ea842bc4-9788-49a9-a7e1-d6e3dd61056a | 2026-06-15 | Warnings | V9BI9B5YI2 |
| Sleep Aid | DOXYLAMINE SUCCINATE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 6d6e47df-a965-4813-8414-9841ed2f9e0c | 2026-06-15 | Warnings | V9BI9B5YI2 |
| pain relief childrens | ACETAMINOPHEN | Rite Aid Corporation | be2286a1-946b-4bf5-b14c-8e86da669594 | 2026-06-15 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.