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 |
|---|---|---|---|---|---|---|
| TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 1c5386c1-e45d-9dcb-e063-6294a90aff07 | 2026-07-22 | Warnings | M012 9D2RTI9KYH V9BI9B5YI2 362O9ITL9D |
| Tylenol Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 103d109d-f520-409c-8da2-eb6b0fbec891 | 2026-07-22 | Warnings | 362O9ITL9D |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | ce58105b-f010-47af-8f31-6dd4ce4e9cba | 2026-07-22 | Warnings | 362O9ITL9D |
| Droptics Dry Eye Relief | CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80 | Droptics LLC | 29d7614b-f4b7-48e2-97c5-d1bff27731d2 | 2026-07-22 | Warnings | PDC6A3C0OX |
| Allergy plus Sinus Headache | ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG | Shield Pharmaceuticals Corp | 772d0184-8c41-40f1-bbef-7e68692eec66 | 2026-07-22 | Warnings | M012 362O9ITL9D |
| good sense allergy | DIPHENHYDRAMINE HCL | L. Perrigo Company | bf5039a0-2109-41a2-84a9-b5167d0a93da | 2026-07-22 | Warnings | M012 |
| GOOD SENSE INFANTS PAIN AND FEVER | ACETAMINOPHEN | L. Perrigo Company | a7cc3964-e8fa-41da-89ca-b0d2aa80f2a7 | 2026-07-22 | Warnings | 362O9ITL9D |
| Congestion and Headache | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 432c3ec4-7595-4213-94e3-ce41af91804e | 2026-07-21 | Warnings | M012 362O9ITL9D |
| SKAPEMED ORIGINAL NASAL | NAPHAZOLINE HCL 0.05% ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a208a1f-f6e8-0b4a-e063-6294a90a10c8 | 2026-07-21 | Warnings | M012 |
| Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation | OCTINOXATE AND TITANIUM DIOXIDE | SICOS ET CIE | 571f23e9-1126-e32d-e063-6294a90a9951 | 2026-07-21 | Warnings | 15FIX9V2JP |
| SERYNTH FAST RELIEF NASAL | NAPHAZOLINE HCL 0.05% FAST RELIEF NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4abdc0-aded-1b8a-e063-6394a90a9b56 | 2026-07-21 | Warnings | M012 |
| DERMFREE ORIGINAL NASAL | NAPHAZOLINE HCL0.05%ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d0c03-7d8f-76cb-e063-6394a90a938c | 2026-07-21 | Warnings | M012 |
| DERMFREE ORIGINAL NASAL | NAPHAZOLINE HCL 0.05%ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a4d3a2b-a4ed-c736-e063-6394a90a96df | 2026-07-21 | Warnings | M012 |
| Sterile Water | WATER | Cardinal Health 107, LLC | 9655cd02-82b5-4a75-813b-854b19551481 | 2026-07-21 | Warnings, Adverse reactions | 059QF0KO0R |
| Severe Cough and Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS PHARMACY | 791eaac1-ddb5-40e2-9040-52dfadc30e06 | 2026-07-21 | Warnings | M012 9D2RTI9KYH |
| Childrens Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | 7562f4e4-54fa-488c-a199-48ad2632e2a1 | 2026-07-21 | Warnings | 362O9ITL9D |
| DRx Choice DAYTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Raritan Pharmaceuticals Inc. | 9ab47b10-b1ed-4ae1-94e8-09d50e952bb0 | 2026-07-21 | Warnings | M012 9D2RTI9KYH 362O9ITL9D |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | P & L Development, LLC | 17639c3b-5d36-41f5-bd0d-da29075abd09 | 2026-07-21 | Warnings | M012 |
| Medline | ACETAMINOPHEN | Medline Industries, LP | 4b1d7243-b943-4e2b-e063-6294a90a2c4e | 2026-07-20 | Warnings | 362O9ITL9D |
| NATUHEAL ORIGINAL NASAL | NAPHAZOLINE HCL 0.05% ORIGINAL NASAL | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a470b9e-c83f-fb20-e063-6294a90a2f13 | 2026-07-20 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.