pseudoephedrine HCl
- Product NDC
- 0904-7669
- 11-digit product format
- 009047669
- Labeler code
- 0904
- Product ID
- 0904-7669_5a3a2755-e348-483f-aa27-087838d2b36d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-09-15
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- pseudoephedrine HCl
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 60 mg/1 |
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 |
|---|---|---|---|---|---|---|
| Signature Care Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | 838d2f11-2ee4-4081-98c8-b87e79aa47c4 | 2024-10-11 | Warnings | M012 |
| Menthol | COUGH SUPPRESSANT | McKesson | 9d4def70-480f-f2fa-e053-2995a90a9877 | 2024-10-10 | Warnings | M012 |
| Menthol | COUGH SUPPRESSANT | McKesson | 9d5b4ef6-4eb8-41f6-e053-2a95a90a1350 | 2024-10-10 | Warnings | M012 |
| Tukol Sugar Free Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Genomma Lab USA | 95e0a3eb-5a58-4c8b-a70b-fb0cca1e0841 | 2024-10-08 | Warnings | M012 |
| Rompe Pecho CF CF | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Efficient Laboratories Inc | 06e96e0c-f21f-e706-e063-6294a90a0780 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | f9f0d020-e031-245e-e053-6294a90addb5 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7ee463-8003-a306-e053-6294a90a8259 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7e4a84-d2c2-65e5-e053-6394a90a0c72 | 2024-10-08 | Warnings | M012 |
| Cough Drops | CHERRY | United Natural Foods, Inc. | f9f0e853-6997-a49b-e053-6294a90aa4b8 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7fa728-911d-aaf0-e053-6394a90ace31 | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f3b84-1e61-eadf-e053-6394a90a9e5c | 2024-10-08 | Warnings | M012 |
| Cough Drops | MENTHOL | United Natural Foods, Inc. | fb7f515f-7302-d153-e053-6394a90a0834 | 2024-10-08 | Warnings | M012 |
| Rompe Pecho NT NT | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Efficient Laboratories Inc | 06faafaa-50a6-c16e-e063-6294a90a49cb | 2024-10-08 | Warnings | M012 |
| Mucus Relief Cough and Congestion DM | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Bryant Ranch Prepack | 8c25285e-e2cd-4e10-af63-5dce8098b615 | 2024-10-08 | Warnings | M012 |
| Severe Throat Sore Drops | MENTHOL | Target Corporation Inc. | 949543d5-5043-ac06-e053-2995a90ab398 | 2024-10-07 | Warnings | M012 |
| Natural Herbal Cough Drops | COUGH DROPS | Target Corporation Inc. | a23ddfa9-19e0-99ee-e053-2a95a90a6856 | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY MENTHOL COUGH DROPS | Perrigo Direct, Inc. | fb809c63-94f1-bb7a-e053-6294a90a0a39 | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY CHERRY COUGH DROPS | Perrigo Direct, Inc. | fb808dc5-bf63-836c-e053-6294a90a80aa | 2024-10-07 | Warnings | M012 |
| Cough Drops | SIMPLY HONEY LEMON | Perrigo Direct Inc. | fb898616-d604-b4c3-e053-6294a90a23bf | 2024-10-07 | Warnings | M012 |
| Natural Herb Cough Drops | MENTHOL HERB | CVS Pharmacy | fcd16063-abca-49a0-e053-6294a90acb26 | 2024-10-07 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0904-7669-06 | 00904766906 | 5 BLISTER PACK in 1 CARTON (0904-7669-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 5 blister pack | 2026-09-15 | No | No | Current |