NDC 35916-0461-03 - Dextromethorphan Hydrobromide
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
- 35916-0461
- Requested NDC
- 35916-0461-03
- Package NDCs from labels
- 35916-0461-1, 35916-0461-2, 35916-0461-3, 35916-0461-4, 35916-0461-03
- Manufacturer
- Softgel Healthcare Pvt Ltd
- Effective date
- 2026-04-27
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Dextromethorphan Hydrobromide - Softgel Healthcare Pvt Ltd | Softgel Healthcare Pvt Ltd | 2026-04-27 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-0461-1 | Dextromethorphan Hydrobromide | 20 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 20 | 5 | |
| 35916-0461-2 | Dextromethorphan Hydrobromide | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | 5 | |
| 35916-0461-3 | Dextromethorphan Hydrobromide | 3000 in 1 POUCH | CAPSULE, LIQUID FILLED | 3000 | 5 | |
| 35916-0461-3 | Dextromethorphan Hydrobromide | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 35916-0461-4 | Dextromethorphan Hydrobromide | 2 in 1 BOX | CAPSULE, LIQUID FILLED | 2 | 5 | |
| 35916-0461-4 | Dextromethorphan Hydrobromide | 1500 in 1 BAG | CAPSULE, LIQUID FILLED | 1500 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 35916-0461 | DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD] | 2 | Current NDC, 6 package rows | 20250321_20f7c1a9-fc4d-1f51-e063-6394a90a8be3.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 |
|---|---|---|---|---|---|---|
| Severe Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Family Dollar Services Inc | ce590997-3cae-4f22-ac39-2b14d39494bc | 2026-07-30 | Warnings | M012 |
| Robitussin Direct Cough | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 70c9556b-063a-4fb3-96f6-1d4ffa495ed4 | 2026-07-30 | Warnings | M012 1090487 9D2RTI9KYH |
| 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 |
| ROBITUSSIN LONG-ACTING COUGHGELS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | 472c5c1f-eb5a-444b-a17e-f0d71007fb15 | 2026-07-29 | Warnings | M012 1090487 9D2RTI9KYH |
| 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 |
| Benadryl | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 702f9786-7ce9-43e4-921d-e1db09612127 | 2026-07-28 | Warnings | M012 |
| DECONIMO Reconstitution | DECONIMO RECONSTITUTION | Image Amazon LLC | 57ab9b1c-9a18-3786-e063-6394a90a2c63 | 2026-07-28 | Warnings | 059QF0KO0R |
| LoHist-D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | efaa354e-c25c-405b-9d30-001c2796978c | 2026-07-28 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | d1115a55-35cd-4f20-8872-f42983a5ebcd | 2026-07-28 | Warnings | M012 9D2RTI9KYH |
| TUSSIN | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Safeway | a5e2bda4-2da6-4c20-855d-2888dadf0c3a | 2026-07-28 | Warnings | M012 9D2RTI9KYH |
| DM Maximum | DEXTROMETHORPHAN HBR, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | f6029b04-e681-40fc-be4f-14091b76dd4e | 2026-07-27 | Warnings | M012 9D2RTI9KYH |
| Allergy Relief | DIPHENHYDRAMINE HCL | CVS PHARMACY | e958eef1-8aae-4365-ac64-95a9e8e7e0f2 | 2026-07-27 | Warnings | M012 |
| Topwin Speedy Enema | GLYCERIN | Health Chemical Pharmaceutical Co., Ltd | 3ba8c3d2-1780-42e1-bec5-8f98771d475e | 2026-07-27 | Warnings | PDC6A3C0OX |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP INC | 38400854-27fa-e291-e063-6294a90a5c4e | 2026-07-27 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Better Living Brands, LLC | 65802aa7-64e7-4435-ad6b-65895fba17ce | 2026-07-27 | Warnings | M012 |
| Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | Walgreen Company | 0a48f650-ad2a-4105-9ff4-2bc4d94b46d3 | 2026-07-27 | Warnings | M012 9D2RTI9KYH |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | 84202ebe-97b6-4be2-bb09-7f2729303f96 | 2026-07-27 | Warnings | M012 9D2RTI9KYH |