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 |
|---|---|---|---|---|---|---|
| daytime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | e0e216ef-300c-4f57-87e6-62a5327e09b4 | 2024-11-08 | Warnings | M012 |
| basic care daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 969c0718-ba6e-4edb-9f55-43bc9500450f | 2024-11-08 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | 62a70d9a-4e78-497c-8f75-012ab94e92f6 | 2024-11-08 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Publix Super Markets Inc | 25b2ad8a-5835-4496-815f-73a7fb40dcfd | 2024-11-08 | Warnings | M012 |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Rite Aid Corporation | 296f20c0-8b5f-4a08-9329-f93c92e63867 | 2024-11-08 | Warnings | M012 |
| topcare tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Topco Associates LLC | d3cae69e-41a5-4099-a3f4-ce25fd94df73 | 2024-11-08 | Warnings | M012 |
| foster and thrive daytime severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strategic Sourcing Services LLC | 9d147d1e-8ea5-4e0f-8ae8-1da16f119496 | 2024-11-08 | Warnings | M012 |
| equate adult cough and chest congestion dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | WALMART INC. | e770bdb2-3662-4538-8199-fe4a4059c720 | 2024-11-08 | Warnings | M012 |
| DG Health Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | 23dcb627-c867-435f-9d1a-a9f49e58b58f | 2024-11-08 | Warnings | M012 |
| good neighbor pharmacy adult tussin DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Amerisource Bergen | ced71993-f535-4e28-bc1d-3fcb7d86e9b7 | 2024-11-08 | Warnings | M012 |
| adult tussin dm | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS Pharmacy | 2f1dc8f8-79c5-4724-99aa-a55330ed9d5f | 2024-11-08 | Warnings | M012 |
| good sense day time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 4ac6b64a-8214-4b03-8aa5-0d3199cf0b72 | 2024-11-08 | Warnings | M012 |
| tussin | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | H E B | 1dd9afb6-9b58-4274-a557-900a0cb23524 | 2024-11-08 | Warnings | M012 |
| DG health sinus severe | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | 7abaa912-be8b-463c-8818-104e79b33539 | 2024-11-07 | Warnings | M012 |
| Extra Strength TYLENOL Cold Plus Flu Multi-Action Day | ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 7d3266dc-879a-4d28-b8ea-74d238c3020a | 2024-11-07 | Warnings | M012 |
| TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 2ddb86a8-e34c-4a03-a60a-d3fedaf90608 | 2024-11-07 | Warnings | M012 |
| Tylenol Cold Plus Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | ce43e5c2-fe96-4462-882c-d7479318b33d | 2024-11-07 | Warnings | M012 |
| TYLENOL SINUS PLUS HEADACHE DAY | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | e608d214-cc46-4a24-ac85-1040e36e7403 | 2024-11-07 | Warnings | M012 |
| Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | e83f7911-22b4-4ffc-8f49-68f6acd2ebf5 | 2024-11-07 | Warnings | M012 |
| Extra Strength TYLENOL Severe Cough Plus Sore Throat Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE. | Kenvue Brands LLC | f81d924e-10e9-0e9d-e053-6294a90a2ddf | 2024-11-07 | 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 |