NDC 35916-0760-01 - Dextromethorphan Hbr,Guaifenesin
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
- 35916-0760
- Requested NDC
- 35916-0760-01
- Package NDCs from labels
- 35916-0760-1, 35916-0760-01
- 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 |
|---|---|---|---|
| Dextromethorphan Hbr,Guaifenesin - 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 |
|---|---|---|---|---|---|---|
| 35916-0760-1 | Dextromethorphan Hbr,Guaifenesin | 1000 in 1 BAG | CAPSULE, LIQUID FILLED | 1000 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 35916-0760 | DEXTROMETHORPHAN HBR,GUAIFENESIN CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD] | 1 | Current NDC, 1 package rows | 20250327_2fbbfc7c-81a9-b647-e063-6394a90a55ac.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 |
|---|---|---|---|---|---|---|
| CVS Severe Nasal Congestion Relief Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | 5a7e42ee-810c-4bc1-9d8d-fac8e849e126 | 2026-08-18 | Warnings | M012 |
| DAYTIME NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Amazon.com Services LLC | 8dd039b4-209a-484a-b15e-741d55087a93 | 2026-08-18 | Warnings | M012 |
| CVS Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | CVS PHARMACY | 558b7ed6-a9f6-452c-90cd-df8258663bf1 | 2026-08-18 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Extra Strength Nasal | PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | 7acf1a9a-bd97-48bb-8025-ac26070378a2 | 2026-08-18 | Warnings | M012 |
| Polytussin DM | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATE | Poly Pharmaceuticals, Inc. | fda8f594-82bf-1781-e053-6294a90ad344 | 2026-08-18 | Warnings | M012 9D2RTI9KYH |
| Mucinex Fast-Max DM Max Honey and Berry Flavor | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | da1f1ef9-a974-4998-8e1d-c1d999596943 | 2026-08-18 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| CVS Health Ultra Fine Mist | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | 89168715-71b1-424e-8dae-fcfa90bc85bf | 2026-08-18 | Warnings | M012 |
| CVS Health Sinus | OXYMETAZOLINE HYDROCHLORIDE | CVS PHARMACY, INC. | c7840511-3a4f-4547-ae90-19b085a5874e | 2026-08-17 | Warnings | M012 |
| CVS Health | NASAL OXYMETAZOLINE HCL | CVS Pharmacy,Inc. | 56f08e70-bf16-4933-97bc-177bc190d12a | 2026-08-17 | Warnings | M012 |
| CVS Health No Drip | ALLERGY NASAL | CVS PHARMACY,INC. | 3e76ffac-07a7-4b6a-bc4c-9cabb653e064 | 2026-08-17 | Warnings | M012 |
| CVS dye-free childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY | db5a5eff-1bb1-4d00-8c01-caae7a1c7223 | 2026-08-17 | Warnings | M012 |
| HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN | ZINC OXIDE,TITANIUM DIOXIDE | Guangzhou Tata Biotechnology Co., Ltd. | 4339df13-77d3-31a1-e063-6394a90a5208 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | HAMBLIN DERMATOLOGY | 5942e64c-416e-7525-e063-6394a90a2839 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Protect Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | Opal Day Spa | 5943413a-48e1-0bdf-e063-6294a90a2fff | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | MedSpa By Beauty Bar LLC | 5943ba3d-688e-9e9c-e063-6294a90afa9a | 2026-08-17 | Warnings | 15FIX9V2JP |
| Stay Ageless Tinted Mineral Sunscreen | BROAD SPECTRUM SPF30 | CORBY, JR., TERRY L. | 594443fd-8e27-4ec6-e063-6294a90a3ff0 | 2026-08-17 | Warnings | 15FIX9V2JP |
| Leader Dry Eye Relief Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | CARDINAL HEALTH 110, LLC. DBA LEADER | 2ded4bda-b3c3-4521-8701-5c8446fd148b | 2026-08-17 | Warnings | B697894SGQ PDC6A3C0OX |
| CVS Overnight Cold and Flu Clear and Cool | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | CVS PHARMACY, INC | 2497a011-d7a0-4d69-97e2-bbf25a99b1cc | 2026-08-17 | Warnings | M012 9D2RTI9KYH |
| Mucus Relief Cough Cold Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | 3ef949f5-ac8c-44be-b04d-6996fa59a94b | 2026-08-17 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Sinus PE Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 28a4ec37-11dd-4134-81aa-851f081bf088 | 2026-08-17 | Warnings | M012 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.