NDC 35916-0188-01 - Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg
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
- 35916-0188
- Requested NDC
- 35916-0188-01
- Package NDCs from labels
- 35916-0188-1, 35916-0188-2, 35916-0188-3, 35916-0188-4, 35916-0188-01
- Manufacturer
- Softgel Healthcare Private Limited
- Effective date
- 2026-04-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| FD&C YELLOW NO. 6 - Softgel Healthcare Private Limited | Softgel Healthcare Private Limited | 2026-04-27 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-0188-1 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | 5 | |
| 35916-0188-2 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 3000 in 1 POUCH | CAPSULE, LIQUID FILLED | 3000 | 5 | |
| 35916-0188-2 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 35916-0188-3 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 2000 in 1 POUCH | CAPSULE, LIQUID FILLED | 2000 | 5 | |
| 35916-0188-3 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 35916-0188-4 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 35916-0188-4 | Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | 1500 in 1 BAG | CAPSULE, LIQUID FILLED | 1500 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 35916-0188 | ACETAMINOPHEN 325MG, DEXTROMETHORPHAN HBR 10MG AND PHENYLEPRINE HCL 5MG (ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PRIVATE LIMITED] | 1 | Current NDC, 7 package rows | 20250322_30ab39f3-27cc-5728-e063-6394a90a9cbe.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 |
|---|---|---|---|---|---|---|
| GOOD NEIGHBOR PHARMACY MUCUS DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amerisource Bergen | f0aea945-1c18-4c6f-a7d1-6d56624011bb | 2026-08-24 | Warnings | 9D2RTI9KYH |
| Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 9be8437c-6053-4ed4-bdd2-97f556b5289e | 2026-08-24 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Genexa Infants Pain and Fever | ACETAMINOPHEN | Genexa Inc. | 4fd048c3-70bc-2ea7-e063-6394a90a55f2 | 2026-08-22 | Warnings | 362O9ITL9D |
| Genexa Kids Pain and Fever | ACETAMINOPHEN | Genexa Inc. | 59adabeb-97e8-2de4-e063-6394a90acc47 | 2026-08-22 | Warnings | 362O9ITL9D |
| Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 594f515c-b369-816d-e063-6294a90a59a1 | 2026-08-21 | Warnings | M012 |
| DG HEALTH MULTI SYMPTOM SEVERE COLD | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Dolgencorp, LLC | 47ddbb0d-0823-4817-9c56-e7fff77d601c | 2026-08-21 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Mucus Relief DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | DOLGENCORP, LLC | 5be4e730-3cd6-414e-a23b-f6cad8088750 | 2026-08-21 | Warnings | M012 9D2RTI9KYH |
| Mucus Relief DM Cough Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Cardinal Health 110, LLC. DBA Leader | 6304a581-9238-4539-b157-293fc05c173e | 2026-08-21 | Warnings | M012 9D2RTI9KYH |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Publix Super Markets Inc | a876daa7-ade3-497d-87bb-46d6e4dc185a | 2026-08-21 | Warnings | 362O9ITL9D |
| Numb520Spray | LIDOCAINE, PHENYLEPHRINE HCL | Ebanel Laboratories, Inc. | 350f0e25-fbdc-c0c0-e063-6294a90a50a0 | 2026-08-20 | Warnings | 04JA59TNSJ |
| Sweat Resistant Sunscreen Body Original | TITANIUM DIOXIDE, ZINC OXIDE | Clutch, Inc. | 4bbde755-e312-123e-e063-6294a90a467f | 2026-08-20 | Warnings | 15FIX9V2JP |
| cough dm | DEXTROMETHORPHAN POLISTIREX | Amazon.com Services LLC | 10f51748-17b1-459d-8cc6-acc4577290aa | 2026-08-20 | Warnings | 9D2RTI9KYH |
| COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ct | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | HyVee Inc | 82ead335-d38e-40c3-8031-222bf985a302 | 2026-08-20 | Warnings | M012 |
| HyVee Nighttime Severe Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 49818610-bf4a-fb86-e063-6294a90ae598 | 2026-08-20 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| HyVee Daytime Severe Cold and Flu SOFTGEL | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | 496ec389-1aea-f202-e063-6394a90ae51c | 2026-08-20 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| Combogesic | ACETAMINOPHEN AND IBUPROFEN | Preferred Pharmaceuticals Inc. | f3cee991-19ef-4a1c-bb14-cbc8b6f32776 | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK | BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL | CVS PHARMACY, INC. | 4d94968b-ada3-4344-8563-cba7fc491d74 | 2026-08-19 | Warnings | M012 |
| CVS Adult Mucus chest congestion | GUAIFENESIN | CVS PHARMACY | bec04049-03b2-4465-9cf5-0ad2ef8014ef | 2026-08-19 | Warnings | M012 |
| CVS Childrens Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | CVS PHARMACY, INC | fe12f3bd-3237-42d1-aec5-c831b9637175 | 2026-08-19 | Warnings | M012 9D2RTI9KYH |
| CVS Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY, INC | bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9 | 2026-08-19 | Warnings | M012 9D2RTI9KYH 04JA59TNSJ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.