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 |
|---|---|---|---|---|---|---|
| Guaifenesin 200mg | GUAIFENESIN | Health Pharma USA LLC | d68222f7-b796-7b27-e053-2995a90a2efe | 2026-07-07 | Warnings | M012 |
| Aussie Betta Tallow Sunscreen SPF50 SPF50 | TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN | AUSSIE BETTA HEALTHY CARE PTY LTD | 56007d82-ff5b-6c26-e063-6294a90a09b6 | 2026-07-07 | Warnings | 15FIX9V2JP |
| Artificial Tears | ARTIFICIAL TEARS | AvPAK | f18bebf2-1936-658f-e053-2a95a90a5012 | 2026-07-07 | Warnings | PDC6A3C0OX |
| Pain Reliever Plus | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Rugby Laboratories | c3df1652-96a8-6043-e053-2995a90a2d26 | 2026-07-07 | Warnings | 362O9ITL9D |
| EELHOE Body Coverage Perfector | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 5610c3b7-456b-3bc1-e063-6394a90a3fa8 | 2026-07-07 | Warnings | 15FIX9V2JP |
| Cold and Flu Severe Day Time / Night Time | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | acdcc6ce-c190-4de6-b126-62fe9043112e | 2026-07-07 | Warnings | M012 |
| Calmco Allergy Relief | DIPHENHYDRAMINE HCL | CalmCo LLC | 471b1a43-1708-8be7-e063-6394a90a9bb7 | 2026-07-06 | Warnings | M012 |
| Dr Kids Pain and Fever | ACETAMINOPHEN | CalmCo LLC | 2ee6df99-727a-34c6-e063-6294a90a6bbc | 2026-07-06 | Warnings | M012 362O9ITL9D |
| Dr Kids Allergy Relief | DIPHENHYDRAMINE HCL | CalmCo LLC | 28ec213e-fabb-28ec-e063-6394a90ad102 | 2026-07-06 | Warnings | M012 |
| Premier Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | Emerald Aesthetics LLC | 55f88dd1-346c-22a5-e063-6294a90a711f | 2026-07-06 | Warnings | 15FIX9V2JP |
| Extra Strength Pain Aid | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Hi-Tech Nutaceuticals, LLC | a39e4b99-700d-0f5c-e053-2a95a90a6bd3 | 2026-07-06 | Warnings | 362O9ITL9D |
| Nighttime Sleep Aid | ACETAMINOPHEN, DIPHENHYDRAMINE | Hi-Tech Nutraceuticals, LLC | a39e2bd6-3d0a-642b-e053-2995a90a42a0 | 2026-07-06 | Warnings | 362O9ITL9D |
| Extra Strength Acetaminophen | ACETAMINOPHEN | Hi-Tech Nutraceuticals, LLC | a36be487-7a36-550f-e053-2a95a90a95c1 | 2026-07-06 | Warnings | 362O9ITL9D |
| Acetaminophen | ACETAMINOPHEN | Hi-Tech Nutraceuticals, LLC | a39c524e-c131-d7fb-e053-2995a90a785b | 2026-07-06 | Warnings | 362O9ITL9D |
| Theraflu Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Select Consumer Group | 55fc7d6f-cc44-b4c0-e063-6294a90ae4fc | 2026-07-06 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Allergy Plus Sinus Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL | DOLGENCORP, LLC | f2eacb1b-8b29-41ec-828a-c1f902ac0934 | 2026-07-06 | Warnings | M012 362O9ITL9D |
| Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g) | NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE) | Reedfresh Co., LTD | 55d703ca-ff9d-0dbc-e063-6294a90ab6b1 | 2026-07-05 | Warnings | PDC6A3C0OX 059QF0KO0R |
| ADVIL DUAL ACTION WITH ACETAMINOPHEN | IBUPROFEN, ACETAMINOPHEN | Select Consumer Group | 55cd65fc-91bf-4979-e063-6294a90ab9b7 | 2026-07-04 | Warnings | 362O9ITL9D |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Select Consumer Group | 55d0dceb-c9a9-778e-e063-6294a90a2ad7 | 2026-07-04 | Warnings | 362O9ITL9D |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Select Consumer Group | 55d10292-e673-9896-e063-6294a90a5674 | 2026-07-04 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.