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 |
|---|---|---|---|---|---|---|
| MUCUS RELIEF DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | db57f6b3-30ca-4a65-9043-f61be24d9b50 | 2026-06-25 | Warnings | 9D2RTI9KYH |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Bryant Ranch Prepack | ee052b39-1658-4071-b081-5433c87b5e4a | 2026-06-25 | Warnings | M012 |
| Acetaminophen | ACETAMINOPHEN | Sportpharm LLC | 830ffcaa-7ff8-4732-bc84-6a8c5e78722d | 2026-06-25 | Warnings | 362O9ITL9D |
| Coral Isle SPF 50 Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Rocky Mountain | 5515f562-62d9-c6ee-e063-6294a90a9ea6 | 2026-06-25 | Warnings | 15FIX9V2JP |
| Delicate Beige Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 551928b4-74bb-3f6c-e063-6294a90a6b83 | 2026-06-25 | Warnings | 15FIX9V2JP |
| Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 5519290c-b040-6a37-e063-6394a90a8a1d | 2026-06-25 | Warnings | 15FIX9V2JP |
| Soft Bisque Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 551ab7d1-dd2f-c6d8-e063-6394a90aff65 | 2026-06-25 | Warnings | 15FIX9V2JP |
| Alabaster Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 551b8c21-3afc-c804-e063-6294a90a5156 | 2026-06-25 | Warnings | 15FIX9V2JP |
| Bare Perfecting Makeup Broad Spectrum SPF 25 | OCTINOXATE, TITANIUM DIOXIDE | Merle Norman Cosmetics, Inc | 552f20b2-9a2e-70f3-e063-6394a90a9337 | 2026-06-25 | Warnings | 15FIX9V2JP |
| Chemstat | GLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, | Energique, Inc. | 2e361b50-9268-4053-b13c-93af64549848 | 2026-06-25 | Warnings | PDC6A3C0OX 506T60A25R |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | DOLGENCORP, LLC | fae1499a-7029-4208-8436-4d330347b915 | 2026-06-25 | Warnings | M012 362O9ITL9D |
| MENSTRUAL COMPLETE | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | Rite Aid Corporation | de723b85-011c-4014-82a8-e813460e3f12 | 2026-06-25 | Warnings | 362O9ITL9D |
| Sinus Pressure and Pain Maximum Strength | ACETAMINOPHEN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | 4fe8f124-ac80-40b4-8e1d-96709c459a4f | 2026-06-25 | Warnings | M012 362O9ITL9D |
| Allergy and Sinus Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 91268cd0-c151-4744-a715-a57af3f3a314 | 2026-06-25 | Warnings | M012 362O9ITL9D |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea | 2026-06-24 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Acetaminophen 650mg | ACETAMINOPHEN | Forreal Pharmaceuticals, LLC | 12a4c301-c052-454e-a8b2-ad626153f5f7 | 2026-06-24 | Warnings | 362O9ITL9D |
| BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN | TITANIUM DIOXIDE | Shantou Woodsleep Biotechnology Co., Ltd. | 54fc80b7-8f6c-e2be-e063-6394a90a4b59 | 2026-06-24 | Warnings | 15FIX9V2JP |
| Fendall 2000 Pure Flow | PURIFIED WATER | Honeywell Safety Products USA, Inc. | 37dead3e-60cb-88ae-e063-6294a90a8f70 | 2026-06-24 | Warnings | 059QF0KO0R |
| MUCUS RELIEF - DM MAXIMUM STRENGTH | GUAIFENESIN, DEXTROMETHORPHAN HBR | YYBA CORP | 4f6da14e-f2ca-cb33-e063-6394a90a9ff8 | 2026-06-24 | Warnings | 9D2RTI9KYH |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.