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 |
|---|---|---|---|---|---|---|
| Meclizine HCL | MECLIZINE HCL 25MG CHEWABLE TABLETS | Aphena Pharma Solutions - Tennessee, LLC | 02d1af4d-d97d-4019-a5bf-3ec391238676 | 2025-01-09 | Warnings | M012 |
| HISTEX PD Drops New Formulation | TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | 0c693f15-5d76-3dbf-e063-6294a90af9ac | 2025-01-08 | Warnings | M012 |
| DEXTROMETHORPHAN HBR 15 MG | DEXTROMETHORPHAN HBR 15 MG | AMZ789 LLC | e2175017-6a0d-0155-e053-2995a90a65d6 | 2025-01-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | Health Pharma USA LLC | 29bb7822-76c6-e39d-e063-6294a90a64fb | 2025-01-07 | Warnings | M012 |
| Childrens Allergy Relief | CHILDRENS ALLERGY RELIEF | Allegiant Health | cb6df361-b8e5-4e2f-945f-c20159d76c4f | 2025-01-06 | Warnings | M012 |
| Nasal Decongestant PE Maximum Strength | PHENYLEPHRINE HCL | WinCo Foods, LLC | bb7a9fed-dc04-4c31-aa7f-4185d955242c | 2025-01-06 | Warnings | M012 |
| Leader Childrens Cold and Cough | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | Cardinal Health 110, LLC. dba Leader | 207b2677-aaad-4fe4-a96d-963b7dcfba70 | 2025-01-06 | Warnings | M012 |
| Allergy Relief Caplet | DIPHENHYDRAMINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | 126c05e7-2cd9-47d3-96c3-82305714e1db | 2025-01-02 | Warnings | M012 |
| Right Remedies Adult Long Lasting Cough Relief Softgel | DEXTROMETHORPHAN HYDROBROMIDE | Strive Pharmaceuticals Inc. | e3ea468e-4e12-4dae-b222-8e32456b77b8 | 2025-01-02 | Warnings | M012 |
| AVON HeXashield Congestion Relief Original | OXYMETAZOLINE HYDROCHLORIDE | Tai Guk Pharm. Co., Ltd. | 8f2c152c-c564-0cba-e053-2a95a90ab3c7 | 2025-01-01 | Warnings | M012 |
| Multi-Symptom Nighttime Cold and Flu Relief | ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR | Advanced Rx LLC | a75553bd-f3f0-47bd-b3c3-aeeb0d1a81b4 | 2025-01-01 | Warnings | M012 |
| Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE | Advanced Rx LLC | 297e10e3-e740-4434-91a2-2e5c54985d33 | 2025-01-01 | Warnings | M012 |
| MUCUS RELIEF DM | GUAIFENESIN, DEXTROMETHORPHAN HBR | Advanced Rx LLC | 64620186-a45b-4c35-a3b9-a347348f93f7 | 2025-01-01 | Warnings | M012 |
| DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Best Choice | 57a44bbf-a304-47b9-8adc-4442c7787853 | 2025-01-01 | Warnings | M012 |
| Long Acting Cough Softgels | DEXTROMETHORPHAN HYDROBROMIDE | CVS PHARMACY, INC | 322daee6-c61d-43d3-a54d-a354fd3df242 | 2025-01-01 | Warnings | M012 |
| Adult Tussin DM Lil Drug Store Products | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Lil' Drug Store Products, Inc | 1915cf2a-ebaa-4c47-8991-5b741fa01be2 | 2024-12-31 | Warnings | M012 |
| Congestion Relief Lil Drug Store Products | OXYMETAZOLINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | 8fca348c-ecb6-4a91-89dd-8bd4c05ac745 | 2024-12-31 | Warnings | M012 |
| DAYTIME COLD AND FLU MULTI SYMPTOM | DAYTIME COLD AND FLU MULTI SYMPTOM | TARGET CORP | 9dea350d-2f09-b944-e053-2995a90a2b63 | 2024-12-30 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb | 2024-12-30 | Warnings | M012 |
| Pediacare Childrens Cough and Cold Grape | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH | fabafdc1-9dd8-4258-af49-bab1e29ad109 | 2024-12-30 | 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 |