Theraflu Severe Cold Relief Daytime
- Product NDC
- 85237-1896
- 11-digit product format
- 852371896
- Labeler code
- 85237
- Product ID
- 85237-1896_55fc88c7-8e44-f123-e063-6294a90adcfd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Select Consumer Group
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-12-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 500; 20 mg/1; mg/1
- Pharmacologic classes
- Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- 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
- Theraflu Severe Cold Relief Daytime
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2670598 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 55fc7d6f-cc44-b4c0-e063-6294a90ae4fc | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| Childrens Allergy Relief | DIPHENHYDRAMINE HCL | Marc Glassman, Inc. | e916ef86-ca73-42dd-83dc-6033f56d96f2 | 2025-12-19 | Warnings | M012 |
| Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Discount Drug Mart | e243033b-6603-4c3e-a330-e7c7de51f69d | 2025-12-19 | Warnings | M012 |
| CHILDRENS ALLERGY | DIPHENHYDRAMINE HYDROCHLORIDE | Discount Drug Mart | 6fa4f913-de83-4175-9dad-0dedab5b69a1 | 2025-12-19 | Warnings | M012 |
| Day-Time COLD/FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | Discount Drug Mart | 426db906-9aa4-448f-a361-09c1516efc25 | 2025-12-19 | Warnings | M012 |
| MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Discount Drug Mart | f17385bc-82bb-4183-a4c9-067d8afb3757 | 2025-12-19 | Warnings | M012 |
| MAXIUM STRENGTH DM MAX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Discount Drug Mart | 9654fdcd-d660-471f-bc5d-aa7dead7a4a8 | 2025-12-19 | Warnings | M012 |
| Night Time Multi-Symptom Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Discount Drug Mart | 8148c2b1-f6ec-4597-8e18-a6597cda5705 | 2025-12-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL 25 MG | NUVICARE LLC | 621ba20e-75c5-42fb-9692-7800f764c978 | 2025-12-19 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL 10 MG | NUVICARE LLC | 4cde41dd-a0a7-45e7-aff3-ee9402dfdff2 | 2025-12-19 | Warnings | M012 |
| COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e | 2025-12-19 | Warnings | M012 |
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2f3df82c-1926-5238-e063-6294a90a7bbf | 2025-12-18 | Warnings | M012 |
| NeoTuss S/F Grape-Menthol Flavor | GUAIFENESIN, DEXTROMETHORPHAN HBR | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2fac3425-32f0-38d6-e063-6394a90a6e7a | 2025-12-18 | Warnings | M012 |
| NAFASOLINA | NAPHAZOLINE HYDROCHLORIDE | Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals | 30cade3d-208f-8594-e063-6394a90ad2a0 | 2025-12-18 | Warnings | M012 |
| Honey Lemon Flavor Cough Drop | HONEY LEMON FLAVOR COUGH DROP | Army & Air Force Exchange Service | 20ac8a20-206c-0024-e063-6394a90a9d06 | 2025-12-18 | Warnings | M012 |
| Menthol Flavor Cough Drop | MENTHOL FLAVOR COUGH DROP | Army & Air Force Exchange Service | 20ace10f-4257-b20e-e063-6394a90a3c7b | 2025-12-18 | Warnings | M012 |
| NeoTuss Plus | DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2fabd782-14dc-1d1b-e063-6394a90af428 | 2025-12-18 | Warnings | M012 |
| NeoTuss Plus | DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals | 2f3c6b38-7236-899b-e063-6294a90aabde | 2025-12-18 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE | MENTHOL | Chain Drug Marketing Association, Inc. | 8f6ee01c-baad-489f-b2fd-0ef506916ee4 | 2025-12-18 | Warnings | M012 |
| menthol cough drops | MENTHOL | Meijer | 5baeaff7-172c-187a-e053-2a91aa0ab165 | 2025-12-18 | Warnings | M012 |
| Menthol Cough Drops | MENTHOL | Meijer Distribution Inc. | 3bee752a-4141-1f5b-e054-00144ff8d46c | 2025-12-18 | Warnings | M012 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85237-1896-1 | 85237189601 | 1 PACKET in 1 BLISTER PACK (85237-1896-1) / 1 POWDER, FOR SOLUTION in 1 PACKET (85237-1896-0) | 1 packet | 2023-12-01 | No | No | Current |
| 85237-1896-3 | 85237189603 | 20 PACKET in 1 CARTON (85237-1896-3) / 1 POWDER, FOR SOLUTION in 1 PACKET (85237-1896-0) | 20 packet | 2023-12-01 | No | No | Current |