NDC 48433-221-05 - GUAIFENESIN AND DEXTROMETHORPHAN HBr
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
- 48433-221
- Requested NDC
- 48433-221-05
- Package NDCs from labels
- 48433-221-05, 48433-221-40
- Manufacturer
- Safecor Health, LLC
- Effective date
- 2023-09-11
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| GUAIFENESIN AND DEXTROMETHORPHAN HBr - Safecor Health, LLC | Safecor Health, LLC | 2023-09-11 | HUMAN OTC DRUG LABEL |
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 |
|---|---|---|---|---|---|---|
| DERMFREE NUMBING | MENTHOL 5% NUMBING | Jiangxi Yudexi Pharmaceutical Co., LTD | 4ca7222b-d754-9861-e063-6294a90a1b7b | 2026-07-24 | Warnings | L7T10EIP3A |
| REINREUDE BACK PAIN THERAPY | CAMPHOR 80MG MENTHOL 24MG CAPSICUM EXTRACT 16MG BACK PAIN THERAPY | Jiangxi Yudexi Pharmaceutical Co., LTD | 4ca7d0ca-6407-1fed-e063-6394a90aaccc | 2026-07-24 | Warnings | L7T10EIP3A |
| REINREUDE BACK PAIN THERAPY | CAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPY | Jiangxi Yudexi Pharmaceutical Co., LTD | 4dfc77bb-11dd-e0f0-e063-6294a90a4e9c | 2026-07-24 | Warnings | L7T10EIP3A |
| DRAVYNOR QUIT SMOKING Patches | NICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHES | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5768631f-d517-5b43-e063-6294a90a8f46 | 2026-07-24 | Warnings | L7T10EIP3A |
| Giltuss Allergy Plus | CHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Gil Pharmaceutical Corp | 85a0dc7f-ffb5-7d52-e053-2991aa0a602a | 2026-07-23 | Warnings | M012 |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Gil Pharmaceutical Corp | 8590fcc9-c0dd-f43b-e053-2991aa0a692e | 2026-07-23 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Giltuss Sinus and Chest Congestion | GUAIFENESIN, PHENYLEPHRINE HCL | Gil Pharmaceutical Corp | 8591003c-c2f2-df65-e053-2a91aa0a42fb | 2026-07-23 | Warnings | M012 495W7451VQ |
| MAG 5 PT WARMING FORMULA | MENTHOL | RENU LABORATORIES, LLC | a499ac9b-0e8e-e23f-e053-2a95a90abe9a | 2026-07-23 | Warnings | L7T10EIP3A |
| COLDTAC Plus | ACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | OPMX LLC | 3496866c-682f-420b-bfdb-64ecebbf70a2 | 2026-07-23 | Warnings | M012 9D2RTI9KYH 495W7451VQ |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Sportpharm LLC | f3afca82-ba8f-4741-8332-b7939aa0ee5e | 2026-07-23 | Warnings, Adverse reactions | 9D2RTI9KYH |
| Icy Hot Performance Cream Pain Relief | MENTHOL 16%, CAMPHOR 11% | Chattem, Inc. | 73f7a113-ef11-4932-bf4d-4e62863f7941 | 2026-07-23 | Warnings | L7T10EIP3A |
| nighttime cough dm | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 5a45b4c2-6a15-40b4-9ac6-d1554244ec42 | 2026-07-23 | Warnings | M012 9D2RTI9KYH |
| DAY TIME NITE TIME INTENSE FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Meijer, Inc. | 6372cbdd-a3a3-499d-91ce-53bcdb83e739 | 2026-07-23 | Warnings | M012 |
| Mucus Relief Extended Release Maximum Strength | GUAIFENESIN | CVS Pharmacy | 34314503-b253-4b44-96ff-a42fe2bb161f | 2026-07-22 | Warnings | 495W7451VQ |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | df6e522c-3e30-4aa0-8ab9-3b579c80bcad | 2026-07-22 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba | 2026-07-22 | Warnings | M012 9D2RTI9KYH |
| TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 1c5386c1-e45d-9dcb-e063-6294a90aff07 | 2026-07-22 | Warnings | M012 9D2RTI9KYH |
| Cooling Pain Relief | MENTHOL 4.5% | Walgreen Company | 24345ccf-c96f-31b0-e063-6294a90a82b5 | 2026-07-22 | Warnings | L7T10EIP3A |
| Moisture Barrier | MENTHOL 0.44%, ZINC OXIDE 20.6% | Walgreen Company | 258f3392-0f42-21e8-e063-6294a90ae9ad | 2026-07-22 | Warnings | L7T10EIP3A |
| Allergy plus Sinus Headache | ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG | Shield Pharmaceuticals Corp | 772d0184-8c41-40f1-bbef-7e68692eec66 | 2026-07-22 | Warnings | M012 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.