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 |
|---|---|---|---|---|---|---|
| AXIV DM Max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | VIVUNT PHARMA LLC | 18704e66-ee8f-315d-e063-6294a90a5282 | 2024-05-14 | Warnings | 495W7451VQ |
| Cold Flu and Sore Throat Relief Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway, Inc. | 6c952c81-c8b6-4e74-abd8-781f6f44736b | 2024-05-14 | Warnings | 495W7451VQ |
| Tussin Cough Sugar Free | DEXTROMETHORPHAN HBR GUAIFENESIN | P & L Development, LLC | 7ed2fe86-3346-4308-a9b6-6a264f879b02 | 2024-05-09 | Warnings | 495W7451VQ |
| Severe Cold and Flu Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | KROGER COMPANY | 10106c90-f2f0-508e-e063-6294a90a544b | 2024-05-08 | Warnings | 495W7451VQ |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger | 10b0e0a0-b878-0a9a-e063-6394a90a20e0 | 2024-05-08 | Warnings | 495W7451VQ |
| Severe Cold and Flu Daytime Honey | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger | 10b0fa3d-d6b2-272a-e063-6394a90a1205 | 2024-05-08 | Warnings | 495W7451VQ |
| QCH Adult Tussin DM 542 | DEXTROMETHORPHAN HBR, GUAIFENESIN | Chain Drug Marketing Association Inc. | 17caffa4-a264-7f3e-e063-6394a90ac419 | 2024-05-08 | Warnings | 495W7451VQ |
| Cough Cold and Sore Throat Childrens | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 400a0998-e276-4c8d-9b41-145b1b405fff | 2024-05-08 | Warnings | 495W7451VQ |
| QCH Adult Tussin DM Sugar free 545 | DEXTROMETHORPHAN HBR, GUAIFENESIN | Chain Drug Marketing Association Inc. | 17cb91f0-32ec-9e0f-e063-6394a90a0509 | 2024-05-08 | Warnings | 495W7451VQ |
| Mucus Congestion and Cough Relief Childrens | DEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCI | Walgreens | 19cd2409-d56b-4319-833c-eacc7dc498c1 | 2024-05-08 | Warnings | 495W7451VQ |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Cardinal Health | c3b40d04-7eef-4c80-a604-808d2be72ad7 | 2024-05-06 | Warnings | 6V9V2RYJ8N |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | Rugby Laboratories | cc6df813-9175-4c0b-a8e4-afcaa3aa833f | 2024-05-06 | Warnings | 6V9V2RYJ8N |
| Robitussin Honey Maximum Strength Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | eaa10aed-5b1e-48bf-bc05-7a5638851daf | 2024-05-03 | Warnings | 495W7451VQ |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL | Haleon US Holdings LLC | e35cb719-9e7d-4b2b-81a4-29e147dd74fa | 2024-05-03 | Warnings | 6V9V2RYJ8N |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL | Haleon US Holdings LLC | 09e20842-2b75-43b9-ae5f-3515b35e655b | 2024-05-03 | Warnings | 6V9V2RYJ8N |
| Tussin CF Non Drowsy Multi Symptom | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WinCo Foods, LLC | 8ee27600-4f8e-406a-8ea3-eade691448f6 | 2024-05-03 | Warnings | 495W7451VQ |
| SanaTos Children Cough and Congestion Cherry | DEXTROMETHORPHAN HBR AND GUAIFENESIN | Pharmadel LLC | 60437d86-9e13-8d8a-e053-2991aa0a2317 | 2024-05-02 | Warnings | 495W7451VQ |
| QCH Adult Tussin 541 | GUAIFENESIN | Chain Drug Marketing Association Inc. | b487f4af-ad0c-4f18-9a6b-7fd386b3f46c | 2024-05-02 | Warnings | 495W7451VQ |
| Mucus Relief 600 mg | GUAIFENESIN | Guardian Drug Company | e7742a43-9066-4e28-a90d-f07c0e18f045 | 2024-04-30 | Warnings | 495W7451VQ |
| Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | CVS Pharmacy | 45d3ad69-a80a-4f91-9c9b-8b19a30144a3 | 2024-04-26 | Warnings | 6V9V2RYJ8N |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.