NDC 62011-0475-01 - Guaifenesin and Pseudoephedrine Hydrochloride
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
- 62011-0475
- Requested NDC
- 62011-0475-01
- Package NDCs from labels
- 62011-0475-1, 62011-0475-01
- Manufacturer
- STRATEGIC SOURCING SERVICES LLC | Ohm Laboratories Inc.
- Effective date
- 2022-02-08
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Guaifenesin and Pseudoephedrine Hydrochloride | STRATEGIC SOURCING SERVICES LLC | Ohm Laboratories Inc. | 2022-02-08 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62011-0475-1 | Guaifenesin and Pseudoephedrine Hydrochloride | 18 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 18 | 2 | |
| 62011-0475-1 | Guaifenesin and Pseudoephedrine Hydrochloride | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 62011-0475 | GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20220210_d139fd8d-66fd-4484-8e78-ed90c505d999.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 |
|---|---|---|---|---|---|---|
| Duraflu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | 55fffc1d-8449-4c28-a391-c6f60dd85622 | 2024-11-09 | Warnings | 6V9V2RYJ8N 495W7451VQ |
| Poly-Vent IR | GUAIFENESIN AND PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | ce0d8c45-446a-4df4-a36b-5000ba69d30d | 2024-11-09 | Warnings | 6V9V2RYJ8N 495W7451VQ |
| basic care tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amazon.com Services LLC | 306d5914-03ed-410a-9345-c54ba604e991 | 2024-11-09 | Warnings | 495W7451VQ |
| Guaifenesin 600 mg | GUAIFENESIN | Strategic Sourcing Services, LLC | 469c5f00-1b6c-6fc7-a352-65764ff25d45 | 2024-11-09 | Warnings | 495W7451VQ |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Walgreen Company | 34174507-cf2e-4ed4-85ec-f915d4b910df | 2024-11-08 | Warnings | 495W7451VQ |
| Sudafed Sinus Congestion 12 Hour | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | d600b5d5-7d95-4ad6-a95b-6d73502743d7 | 2024-11-08 | Warnings | 6V9V2RYJ8N |
| SUDAFED Sinus Congestion | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | c05d7e27-6821-468f-b27d-9c0b02a07b0f | 2024-11-08 | Warnings | 6V9V2RYJ8N |
| Childrens Sudafed Nasal Decongestant | PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | 52e9307b-ad38-4f65-bb2f-4fa262e82010 | 2024-11-08 | Warnings | 6V9V2RYJ8N |
| Sudafed Sinus 12 Hour Pressure plus Pain | NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE | Kenvue Brands LLC | 305adca3-cdae-41e5-a10a-99d9dd0fe390 | 2024-11-08 | Warnings | 6V9V2RYJ8N |
| SUDAFED PE Head Congestion Plus Mucus | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | f0739186-41b9-4761-adf7-08101b30a18e | 2024-11-08 | Warnings | 495W7451VQ |
| SUDAFED PE Head Congestion Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 1e528f78-0ced-4a06-935a-84056c921727 | 2024-11-08 | Warnings | 495W7451VQ |
| daytime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | e0e216ef-300c-4f57-87e6-62a5327e09b4 | 2024-11-08 | Warnings | 495W7451VQ |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 969c0718-ba6e-4edb-9f55-43bc9500450f | 2024-11-08 | Warnings | 495W7451VQ |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | 62a70d9a-4e78-497c-8f75-012ab94e92f6 | 2024-11-08 | Warnings | 495W7451VQ |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Publix Super Markets Inc | 25b2ad8a-5835-4496-815f-73a7fb40dcfd | 2024-11-08 | Warnings | 495W7451VQ |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Rite Aid Corporation | 296f20c0-8b5f-4a08-9329-f93c92e63867 | 2024-11-08 | Warnings | 495W7451VQ |
| topcare tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Topco Associates LLC | d3cae69e-41a5-4099-a3f4-ce25fd94df73 | 2024-11-08 | Warnings | 495W7451VQ |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 9d147d1e-8ea5-4e0f-8ae8-1da16f119496 | 2024-11-08 | Warnings | 495W7451VQ |
| equate adult cough and chest congestion dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | WALMART INC. | e770bdb2-3662-4538-8199-fe4a4059c720 | 2024-11-08 | Warnings | 495W7451VQ |
| DG Health Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | 23dcb627-c867-435f-9d1a-a9f49e58b58f | 2024-11-08 | Warnings | 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.