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 |
|---|---|---|---|---|---|---|
| VANACOF DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | GM Pharmaceuticals, INC | 2ed699f2-d004-4fa9-8042-6c85a9ff69b6 | 2025-11-03 | Warnings | M012 |
| Geri Dryl | DIPHENHYDRAMINE HCL | VERITYRX, LLC | 42a05f69-0599-5571-e063-6394a90a37d3 | 2025-11-02 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | VERITYRX, LLC | 42a0e577-a1b6-2c16-e063-6294a90af8e3 | 2025-11-02 | Warnings | M012 |
| Severe Sinus Congestion and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE | Shield Pharmaceuticals Corp | c296efd0-5030-4a26-a9b0-e66423d995dc | 2025-10-31 | Warnings | M012 |
| Daytime Cold and Flu Max Maximum Strength Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Topco Associates, LLC | f7ebe482-cb22-4517-8463-3432cf60071d | 2025-10-31 | Warnings | M012 |
| Nighttime Cold and Flu Max Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates, LLC | 787bff76-0ee2-4e7e-b908-876e4a3e3bfc | 2025-10-31 | Warnings | M012 |
| Honey Lemon Cough Drops | MENTHOL | Trader Joe's Company | 647dadae-f37a-8399-e053-2991aa0aedb3 | 2025-10-31 | Warnings | M012 |
| Family Care Saline | SODIUM CHLORIDE | United Exchange Corp. | 06737393-d4ae-3e7b-e063-6394a90ac19f | 2025-10-31 | Warnings | M012 |
| QUALITY CHOICE Maximum Strength Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | 40416ff5-06e1-97dd-e063-6394a90a2046 | 2025-10-30 | Warnings | M012 |
| Robitussin Maximum Strength Nighttime Cough DM | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 44feee2f-25bc-48d4-8e13-db1d9daaaa90 | 2025-10-30 | Warnings | M012 |
| Robitussin Day and Night Cough Relief DM Max | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | b3d02c91-8f79-4eb4-a378-1072474c572c | 2025-10-30 | Warnings | M012 |
| ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7 | 2025-10-30 | Warnings | M012 |
| Endal | TRIPROLIDINE HCL, DEXTROMETHORPHAN HBR | Poly Pharmaceuticals, Inc. | fc5401e2-ed65-72e7-e053-6294a90a81f3 | 2025-10-30 | Warnings | M012 |
| daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Publix Super Markets Inc | c7cef266-46fc-49ab-a2e7-54fc56298659 | 2025-10-30 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | SAM'S WEST INC | 16592ad7-b7cb-0837-e063-6394a90ae059 | 2025-10-29 | Warnings | M012 |
| Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL | SAFEWAY | 013b94a1-26c7-4371-981a-d1b9d7fd1c98 | 2025-10-29 | Warnings | M012 |
| Better Living | PHENYLEPHRINE HYDROCHLORIDE | BETTER LIVING BRANDS LLC | aea0db7f-e01a-4d8e-9c20-4a5ef4a905d1 | 2025-10-29 | Warnings | M012 |
| AXIM DayTime - Night Time 72 Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | VIVUNT PHARMA LLC | de9eb2d5-ba51-4637-e053-2995a90a0451 | 2025-10-29 | Warnings | M012 |
| Dollar General Vapor Steam | CAMPHOR (SYNTHETIC) | DOLGENCORP, LLC | 86d0f3ac-1359-c2f9-e053-2a91aa0a35d0 | 2025-10-29 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | 5d628b09-c257-4369-8ddb-47554d83c0d8 | 2025-10-29 | 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 |