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 |
|---|---|---|---|---|---|---|
| G-Supress DX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 5dd44337-f3aa-4e73-a206-4a29850a2f7c | 2025-11-12 | Warnings | 495W7451VQ |
| PRESGEN PEDIATRIC | GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE | KRAMER NOVIS | 12fb91e5-6059-4b3a-a2de-762aa51a25b7 | 2025-11-12 | Warnings | 495W7451VQ |
| Sorbugen | DEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATE | Kramer Novis | a8f2a2d7-0360-45a8-9635-c852f4a7d7ba | 2025-11-12 | Warnings | 495W7451VQ |
| DESGEN DM | DEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCL | Kramer Novis | 6ab47174-e1fd-47ce-8788-06b7cdad5218 | 2025-11-12 | Warnings | 495W7451VQ |
| Presgen | GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Kramer Novis | edad7a86-0d27-4a98-85b2-4b6725904f28 | 2025-11-12 | Warnings | 495W7451VQ |
| TUSSI PRES PEDIATRIC | GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE | KRAMER NOVIS | b01a45df-3cea-4729-80c1-7f35b7f707f0 | 2025-11-12 | Warnings | 495W7451VQ |
| TUSICOF | DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE | Kramer Novis | e966b75c-4bb4-4216-8247-baada8f5d759 | 2025-11-12 | Warnings | 495W7451VQ |
| Fast Acting Mucus Relief Maximum Strength Severe Cough and Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 52327ed0-ea49-4d1c-b928-20ab381be9f2 | 2025-11-11 | Warnings | 495W7451VQ |
| Mucus Relief | GUAIFENESIN | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 32f58b4a-3e1b-424f-8296-a9bf9a7d7025 | 2025-11-11 | Warnings | 495W7451VQ |
| TOPCO Childrens Cough Relief | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Topco Associates, LLC | ee0f5627-5104-4990-88ee-2fb46965bc1e | 2025-11-11 | Warnings | 495W7451VQ |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b4a2a-d6bf-ec25-e063-6294a90a3f06 | 2025-11-11 | Warnings | 495W7451VQ |
| TYLENOL Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435e6387-1ee0-c20f-e063-6294a90adac5 | 2025-11-11 | Warnings | 495W7451VQ |
| Mucus Relief DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 2426bf76-19bf-4bfd-8f9e-3b348e4b5641 | 2025-11-11 | Warnings | 495W7451VQ |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | 103de130-ef12-4c58-bbcf-234b3f3b2cbf | 2025-11-08 | Warnings | 495W7451VQ |
| Guaifenesin | GUAIFENESIN | WALGREEN CO. | 51a35002-77ba-47e5-93ab-3f28242d16b6 | 2025-11-07 | Warnings | 495W7451VQ |
| G-TUSICOF | DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE | Kramer Novis | d169585f-b4f4-4831-8c71-e1533ae7e7c4 | 2025-11-07 | Warnings | 495W7451VQ |
| Sinus Congestion | PSEUDOEPHEDRINE HCL | Chain Drug Marketing Association, Inc. | 9744d04d-298d-4acd-9470-db9e7f2901e7 | 2025-11-07 | Warnings | 6V9V2RYJ8N |
| Guaifenesin | GUAIFENESIN | WALGREEN CO. | 0c329d9f-8f1e-4b41-a03b-324e5d1b4ae2 | 2025-11-07 | Warnings | 495W7451VQ |
| Target Cough plus Chest Congestion DM Max with Honey | DEXTROMETHORPHAN HBR, GUAIFENESIN | TARGET CORPORATION | e36f179e-5aed-4fee-8b0a-767bf3590752 | 2025-11-05 | Warnings | 495W7451VQ |
| Target Maximum Strength Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORPORATION | 1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d2 | 2025-11-05 | Warnings | 495W7451VQ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.