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 |
|---|---|---|---|---|---|---|
| nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | f1d0edd5-fe58-4de0-98f4-07fb24bd0ac2 | 2025-02-19 | Warnings | M012 |
| Coricidin HBP Cold and Flu | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | Bayer HealthCare LLC. | 763a5334-a741-4678-9947-603776622450 | 2025-02-18 | Warnings | M012 |
| Sof Skin Vaporizing Chest Rub and Cough Suppressant | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Viny Health and Beauty Inc | 46ae16a4-b8a7-44de-ae1a-9bb503c15ea0 | 2025-02-18 | Warnings | M012 |
| Pain Reliever PM | ACETAMINOPHEN DIPHENHYDRAMINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 4897d1df-4fb3-46e2-bbf0-847e964dca0a | 2025-02-18 | Warnings | M012 |
| meijer EXTRA STRENGTH Pain Relief PM Caplet | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 1bee7e4f-1813-1bdf-e063-6294a90a6a32 | 2025-02-17 | Warnings | M012 |
| ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCL | Kroger Company | a24f09d9-60f1-853a-e053-2a95a90ae1fa | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGTH COLD AND FLU | ACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | FAMILY DOLLAR SERVICES | a7343bea-53cc-4621-e053-2a95a90a2a5f | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8f6dd0-d19f-0c10-e053-2a95a90a1e8a | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENGHT DAY COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8ebccf-6813-2dca-e053-2a95a90a032b | 2025-02-15 | Warnings | M012 |
| MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | FAMILY DOLLAR | aa8f0465-1595-0b0f-e053-2a95a90a0081 | 2025-02-15 | Warnings | M012 |
| DAYTIME SEVERE COLD AND FLU | ACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESIN | KROGER COMPANY | 9bb7aaf0-6698-9a5c-e053-2a95a90a097c | 2025-02-14 | Warnings | M012 |
| Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | H-E-B | db432947-fe02-79b2-e053-2a95a90af4a9 | 2025-02-14 | Warnings | M012 |
| Halls Sugar Free Cherry | MENTHOL | Mondelez Global LLC | ea8dfe96-f6a4-4172-bf9e-ae3cf606ff50 | 2025-02-14 | Warnings | M012 |
| Halls Sugar Free Watermelon | MENTHOL | Mondelez Global LLC | c4c090ca-f083-74e0-e053-2a95a90a9d60 | 2025-02-14 | Warnings | M012 |
| Tukol Max Action | OXYMETAZOLINE HYDROCHLORIDE | Genomma Lab USA | 73358103-43dc-4b11-9c89-9a6ba45bf1af | 2025-02-14 | Warnings | M012 |
| Maximum Strength Mucus Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Chain Drug Marketing Association Inc. | 6c4e867b-24b9-4525-9fab-10f1e7910b13 | 2025-02-13 | Warnings | M012 |
| DAYTIME- NIGHTTIME COLD AND FLU | DAYTIME NIGHTTIME COLD AND FLU | TARGET CORP | 9def204a-ee1e-6868-e053-2995a90a76b8 | 2025-02-13 | Warnings | M012 |
| Daytime Cold and Flu and Nigttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | f2c11b63-278f-64de-e053-2995a90a5aae | 2025-02-12 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | BETTER LIVING BRANDS LLC. | f29c604a-271d-a702-e053-2a95a90a3427 | 2025-02-12 | Warnings | M012 |
| Nighttime cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | BETTER LIVING BRANDS LLC. | f2c01090-645c-1efe-e053-2995a90a7df5 | 2025-02-12 | 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 |