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 |
|---|---|---|---|---|---|---|
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | 30d41dc3-e2ef-4cad-b63c-d634bc749aa1 | 2025-12-09 | Warnings | 495W7451VQ |
| Mucus Relief DM | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Meijer Distribution Inc | 8ed5b802-a26e-45b4-a696-bc64dbac4733 | 2025-12-09 | Warnings | 495W7451VQ |
| Mucolyte | GUAIFENESIN | Rising Pharma Holdings, Inc. | e4091aaf-44e3-4701-9986-aff248a2f1b8 | 2025-12-08 | Warnings | 495W7451VQ |
| Mucolyte DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Rising Pharma Holdings, Inc. | c913d27d-bc00-4ace-9a5f-c55522e1cd1d | 2025-12-08 | Warnings | 495W7451VQ |
| Guaifenesin | GUAIFENESIN | Health Pharma USA LLC | 31755594-3e1c-b290-e063-6394a90aba61 | 2025-12-05 | Warnings | 495W7451VQ |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | d0dd4a75-da65-4c66-b65f-54ee14100846 | 2025-12-05 | Warnings | 495W7451VQ |
| Mucus Relief | GUAIFENESIN | NUVICARE LLC | d6734345-29a1-4356-a063-ff37ed4fbe9a | 2025-12-05 | Warnings | 495W7451VQ |
| Mucus Relief | GUAIFENESIN | Pioneer Life Sciences, LLC | d635b228-a51f-42d9-885c-3cd566fd352b | 2025-12-04 | Warnings | 495W7451VQ |
| Childrens Mucus Relief Chest Congestion | GUAIFENESIN | Chain Drug Manufacturing Assn | 034d39c0-9aad-4dff-a158-a041b9f0504f | 2025-12-04 | Warnings | 495W7451VQ |
| Childrens Mucus and Cough Relief | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Chain Drug Manufacturing Assn | 06822a28-3f82-471d-8db5-c5981b263a03 | 2025-12-04 | Warnings | 495W7451VQ |
| Mucinex | GUAIFENESIN | ATLANTIC BIOLOGICAS CORP. | 40c67cca-f202-4652-9507-2442d26cfd67 | 2025-12-04 | Warnings | 495W7451VQ |
| Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | a6a2dd4a-a3c8-2dfa-e053-2995a90ada86 | 2025-12-04 | Warnings | 495W7451VQ |
| Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Bayer Healthcare LLC. | a32e2a5e-9aa0-4e7c-e053-2995a90a3190 | 2025-12-04 | Warnings | 495W7451VQ |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels | ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION | Bayer HealthCare LLC. | 0c120569-622d-3a23-e054-00144ff88e88 | 2025-12-04 | Warnings | 495W7451VQ |
| Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 0dba1329-5b0d-5688-e054-00144ff8d46c | 2025-12-04 | Warnings | 495W7451VQ |
| Aleve-D Sinus and Headache | NAPROXEN SODIUM, PSEUDOEPHEDRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5ab980c0-c48a-233b-e053-2991aa0a4fd1 | 2025-12-04 | Warnings | 6V9V2RYJ8N |
| Aleve-D Sinus and Cold | NAPROXEN SODIUM, PSEUDEOEPHEDRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 599ea6c8-03ad-536e-e053-2991aa0a83a3 | 2025-12-04 | Warnings | 6V9V2RYJ8N |
| Coricidin HBP Maximum Strength Cold Flu And Chest Congestion | ACETAMINOPHEN, GUAIFENESIN | Bayer HealthCare LLC. | de95d2dd-e766-f7ec-e053-2995a90afc5f | 2025-12-04 | Warnings | 495W7451VQ |
| Desgen Pediatric | DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL | Kramer Novis | 12425c1b-8bdc-446b-83dd-95e05a4d9b8c | 2025-12-04 | Warnings | 495W7451VQ |
| Topco Mucus Relief | GUAIFENESIN | Topco Associates, LLC | 03c17c06-6919-4ef4-9d0a-4c039940c671 | 2025-12-03 | Warnings | 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.