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 |
|---|---|---|---|---|---|---|
| Pain Relief Acetaminophen 325 mg | ACETAMINOPHEN | NUVICARE LLC | 49a59b79-b8b4-4bf5-a403-0a14751efc55 | 2026-07-30 | Warnings | 362O9ITL9D |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Lifestar Pharma LLC | 1767c4b7-36a0-4e64-9091-2af22161402f | 2026-07-30 | Warnings, Adverse reactions | 04JA59TNSJ |
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | ce590997-3cae-4f22-ac39-2b14d39494bc | 2026-07-30 | Warnings | M012 04JA59TNSJ 362O9ITL9D |
| Robitussin Direct Cough | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 | 2026-07-30 | Warnings | M012 9D2RTI9KYH |
| KinderFarms Childrens Pain and Fever | ACETAMINOPHEN | KinderFarms, LLC | 4f86419a-b940-a9c6-e063-6394a90a6a2b | 2026-07-30 | Warnings | 362O9ITL9D |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | Lifestar Pharma LLC | f43e4abd-0083-4fe5-9c27-0ba9245e5138 | 2026-07-30 | Warnings, Adverse reactions | 04JA59TNSJ |
| Major Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | a302e341-1c00-4c3d-b71f-c4c0b307aa67 | 2026-07-29 | Warnings | M012 |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreens | 4c737cd6-fe56-4cef-887c-cd6cf83b254c | 2026-07-29 | Warnings | M012 362O9ITL9D |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 4c966d73-77c6-4514-954e-57aa06a080c6 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| ROBITUSSIN LONG-ACTING COUGHGELS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 472c5c1f-eb5a-444b-a17e-f0d71007fb15 | 2026-07-29 | Warnings | M012 9D2RTI9KYH |
| KinderFarms Infants Pain and Fever | ACETAMINOPHEN | KinderFarms, LLC | 5468b149-8fac-8d6a-e063-6294a90a8c51 | 2026-07-29 | Warnings | 362O9ITL9D |
| DAYTIME COLD AND FLU NITETIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Meijer Distribution Inc | 3a33c6ce-aada-4099-8c61-49c86c0fc1a8 | 2026-07-29 | Warnings | M012 |
| Tussin DM Max Nighttime | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 668c92ce-6c1f-4ab3-b0dd-822b0768cb5e | 2026-07-29 | Warnings | M012 9D2RTI9KYH |
| RUGBY MUCUS RELIEF DM ER | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rugby Laboratories | 8090d561-0478-435d-ad6f-2334e1823bc3 | 2026-07-28 | Warnings | 9D2RTI9KYH |
| PERCOCET | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | Endo USA, Inc. | 4dd36cf5-8f73-404a-8b1d-3bd53bd90c25 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 702f9786-7ce9-43e4-921d-e1db09612127 | 2026-07-28 | Warnings | M012 |
| oxycodone and acetaminophen | OXYCODONE AND ACETAMINOPHEN | FH2 Pharma LLC | 88d97caf-bcf5-3cde-e053-2995a90acf4a | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| DECONIMO Reconstitution | DECONIMO RECONSTITUTION | Image Amazon LLC | 57ab9b1c-9a18-3786-e063-6394a90a2c63 | 2026-07-28 | Warnings | 059QF0KO0R |
| Prolate | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | Forte Bio-Pharma LLC | 9d75ad3b-bc9b-0c22-e053-2a95a90ac71e | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 362O9ITL9D |
| LoHist-D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | efaa354e-c25c-405b-9d30-001c2796978c | 2026-07-28 | Warnings | M012 |