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 |
|---|---|---|---|---|---|---|
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | WALMART INC. | a9d5f9f4-ddec-4ad6-ad06-4a612008bb68 | 2026-06-17 | Warnings | M012 |
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Walgreen Company | e49d2a0f-6588-439b-8a46-c073e0bc4f9a | 2026-06-17 | Warnings | M012 |
| COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Safeway | ac0380ad-c9fa-4bda-ab84-c2e6aa672bdf | 2026-06-17 | Warnings | M012 9D2RTI9KYH V9BI9B5YI2 362O9ITL9D |
| Humalog | INSULIN LISPRO | Eli Lilly and Company | c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f | 2026-06-16 | Warnings, Adverse reactions | 059QF0KO0R |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 1a21cbb2-1ba5-414f-a31f-42b7a7bddae5 | 2026-06-16 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Tussin DM Regular | DEXTROMETHORPHAN HBR AND GUAIFENESIN | AARNA USA, Inc. | 5460c809-71c8-3ad6-e063-6294a90a4e4f | 2026-06-16 | Warnings | M012 9D2RTI9KYH |
| GlowBiotics Tinted Sunscreen SPF 30 | ZINC OXIDE | Rum Brands, LLC | 544dba29-4785-4ab6-e063-6394a90a17b3 | 2026-06-16 | Warnings | 15FIX9V2JP |
| Societe Prime and Defend | ZINC OXIDE SUNSCREEN | Societe Clinical Skincare | 5439bd31-5ee1-9bca-e063-6394a90a748c | 2026-06-16 | Warnings | 15FIX9V2JP |
| Societe CoverShield Tinted SPF | ZINC OXIDE | Societe Clinical Skincare | 545efbc4-82d4-f126-e063-6294a90a9710 | 2026-06-16 | Warnings | 15FIX9V2JP |
| Glycerin | GLYCERIN SUPPOSITORY | Everpharm LLC | 546347e5-841e-15ca-e063-6294a90a0c8b | 2026-06-16 | Warnings | PDC6A3C0OX |
| Glycerin | GLYCERIN SUPPOSITORY | Everpharm LLC | 5463f869-2b92-4551-e063-6394a90ad6f9 | 2026-06-16 | Warnings | PDC6A3C0OX |
| MINICA-S | GLYCERIN | Sato Pharmaceutical Co., Ltd. | 687902eb-e702-4e87-a0ce-9add05e3cbc1 | 2026-06-16 | Warnings | PDC6A3C0OX |
| Childrens Pain and Fever Relief | ACETAMINOPHEN | Chain Drug Marketing Association, Inc. | 420a1e05-caa6-481f-bdab-a670f0220f96 | 2026-06-16 | Warnings | 362O9ITL9D |
| Equate Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALMART INC. | 4b111580-cd20-43ec-9ff4-4b9f74f7d2e8 | 2026-06-16 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Sinus Congestion | PHENYLEPHRINE HCL | Chain Drug Marketing Association, Inc. | 43a77f89-e66a-4db6-8067-f614c0e207df | 2026-06-16 | Warnings | M012 |
| Pain Relief Extra Strength | ACETAMINOPHEN | DOLGENCORP, LLC | ce9f4e0d-43fb-499a-b8a2-a997a14841c4 | 2026-06-16 | Warnings | 362O9ITL9D |
| severe sinus congestion relief Maximum Strength | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 51175d3e-e1c3-4e4d-ad32-61600e87568c | 2026-06-16 | Warnings | M012 362O9ITL9D |
| foster and thrive daytime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Strategic Sourcing Services LLC | 067ce5de-dbb4-4b65-8ec0-f4aacbe5e0a6 | 2026-06-16 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Equate Severe Cold Cough and Flu | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | a35531d7-1a96-45cb-922f-61db085cde1f | 2026-06-16 | Warnings | M012 362O9ITL9D |
| Pain Reliever | ACETAMINOPHEN | L.N.K. International, Inc. | 734cc3d2-6fc5-4dcc-93ed-0b57c1f01345 | 2026-06-15 | Warnings | 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.