Daytime Cold and Flu
- Product NDC
- 51316-421
- 11-digit product format
- 513160421
- Labeler code
- 51316
- Product ID
- 51316-421_70d0e6d8-8206-4daa-b704-765e6d7f67a4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- CVS PHARMACY, INC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-05-31
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 325; 10 mg/15mL; mg/15mL
- 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
- Daytime Cold and Flu
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2604561 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-421-12 | Daytime Cold and Flu | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | 5 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Pentrexcilina Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | e11e5c17-28f2-7186-e053-2995a90a51f6 | 2025-07-17 | Warnings | M012 |
| Viro Flu PM Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | e1553da8-3a89-e258-e053-2a95a90a4725 | 2025-07-17 | Warnings | M012 |
| ACTICON PEDIATRIC | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 3052cc67-e6c0-4d3f-9ec9-ffe58d9fae23 | 2025-07-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Demoulas Super Markets, Inc | 397f5acd-31c0-683e-e063-6394a90a7e54 | 2025-07-16 | Warnings | M012 |
| EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE | Kenvue Brands LLC | 19ad2cca-c1cb-019c-e063-6294a90a5644 | 2025-07-16 | Warnings | M012 |
| DG HEALTH COLD FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Dolgencorp Inc | 8ea03891-2fbc-4413-8e6d-de903d426f8d | 2025-07-16 | Warnings | M012 |
| up and up nighttime flu and severe cold and cough | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | df488727-b913-440b-9a0b-cce3ae143bf2 | 2025-07-15 | Warnings | M012 |
| Topcare DayTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates LLC | bb9663e3-fd11-4e72-bf85-fee4841b795f | 2025-07-15 | Warnings | M012 |
| DG HEALTH COLD FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Dolgencorp Inc | 320e4f32-66aa-48be-9afd-fa2b2c217dc1 | 2025-07-14 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | BETTER LIVING BRANDS LLC. | f29da4ca-443d-7035-e053-2a95a90acab8 | 2025-07-14 | Warnings | M012 |
| CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS PHARMACY | cdc9af7c-3766-4573-9d95-bf217907b932 | 2025-07-11 | Warnings | M012 |
| Health Smart Vaporizing Chest Rub | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | International Wholesale Inc | 398fee3d-7d93-9dbc-e063-6294a90abdcc | 2025-07-10 | Warnings | M012 |
| HEADACHE RELIEF | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Kroger Company | bbed29a1-3c52-3531-e053-2995a90a686c | 2025-07-10 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS PHARMACY, INC | b765c82e-5021-4772-8647-c5ebc596bc0a | 2025-07-10 | Warnings | M012 |
| Sinus Pressure and Pain | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | c378acaf-389a-4afb-a4f0-e367a907a468 | 2025-07-10 | Warnings | M012 |
| Nasal Decongestant Non-Drowsy | PSEUDOEPHEDRINE HCL | CVS Pharmacy | 3330b077-dab7-45c6-acbb-0f91f2271232 | 2025-07-09 | Warnings | M012 |
| ACTIDOGESIC DF | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | ACTIPHARMA, LLC | ff8e2565-bce3-4c06-a416-6e8f369f057f | 2025-07-09 | Warnings | M012 |
| ACTINEL | DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL | ACTIPHARMA, LLC | db0cb6ae-0a4d-4232-805a-f3f3a058261f | 2025-07-08 | Warnings | M012 |
| HALLS Extra Strong | MENTHOL | Mondelez Global LLC | 396f93a9-8d2c-2f27-e063-6294a90ab344 | 2025-07-08 | Warnings | M012 |
| ACTICON | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIPHARMA, LLC | aea0335d-75e6-4a90-86a5-f197cf024a11 | 2025-07-08 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral Solution | PSN | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SCD | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral Solution | SY | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral Solution | SY | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
| 2604561 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral Solution | SY | 1b8d5494-1fcf-4cd0-acc0-34f17d577bd7 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51316-421-12 | 51316042112 | 355 mL in 1 BOTTLE, PLASTIC (51316-421-12) | 355 ml | 2024-05-31 | No | No | Current |