Nighttime Cold and Flu Relief
- Product NDC
- 21130-044
- 11-digit product format
- 211300044
- Labeler code
- 21130
- Product ID
- 21130-044_72bb25dc-3f0f-4afe-b967-dc5f14ff1767
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Safeway, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-06-30
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
- Nighttime Cold and Flu Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1043400 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 164b2559-2d3f-431e-a03c-07e86731af5c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21130-044-08 | Nighttime Cold and Flu Relief | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | 9 | |
| 21130-044-12 | Nighttime Cold and Flu Relief | 355 mL in 1 BOTTLE | LIQUID | 355 | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 21130-044 | NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [SAFEWAY, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241105_164b2559-2d3f-431e-a03c-07e86731af5c.zip |
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 |
|---|---|---|---|---|---|---|
| Medique Chlorphen | CHLORPHENIRAMINE MALEATE | Unifirst First Aid Corporation | b3d5d161-8d4c-f1bb-e053-2a95a90a5bc5 | 2025-09-08 | Warnings | M012 |
| Crane Safety Sinus Decongestant | PHENYLEPHRINE HYDROCHLORIDE | Crane Safety LLC | 968baa85-ce0e-0c3d-e053-2995a90ac03a | 2025-09-08 | Warnings | M012 |
| Thompson Cherry Cough Drops | MENTHOL | Thompson Safety LLC | c948f5b0-8491-6f9f-e053-2995a90a55fa | 2025-09-08 | Warnings | M012 |
| Medique Decorel Forte | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Unifirst First Aid Corporation | e64c283b-0efa-0bfd-e053-2a95a90ab71d | 2025-09-08 | Warnings | M012 |
| Daytime Nighttime Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE | Walgreens | a99fdd49-0160-4a82-983b-fa56ab38ae76 | 2025-09-08 | Warnings | M012 |
| Dye Free Wal Dryl Allergy childrens | DIPHENHYDRAMINE HYDROCHLORIDE | Walgreens | 53e6f72d-15a4-4efe-8b1f-5753fed53df8 | 2025-09-08 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreens | 40bfd631-51a4-4684-9ba0-a365d61da9bc | 2025-09-08 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | f796ce1f-3077-4a0d-a41a-249c345ddb5f | 2025-09-08 | Warnings | M012 |
| equate nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 6ccbd537-2264-4b3c-804e-3d3ea5368a5f | 2025-09-05 | Warnings | M012 |
| Ephedrine Sulfate | EPHEDRINE SULFATE | Walgreen Company | dc0072f9-7111-1af0-e053-2a95a90aed56 | 2025-09-04 | Warnings | M012 |
| Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS Pharmacy, Inc | 31aa77e0-cfdb-57a8-e063-6394a90af98c | 2025-09-04 | Warnings | M012 |
| Effervescent Orange Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | CVS Pharmacy, Inc. | 4bb70a55-de44-3dc1-e054-00144ff8d46c | 2025-09-04 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | CVS PHARMACY | a645b31e-7da7-4fe6-a04f-ac794ef52494 | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de637b1-3402-db86-e063-6294a90ac981 | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Medical Group Care LLC | f4a9cfec-0725-8f4a-e053-2995a90a1b4a | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de65c99-6c2d-3650-e063-6394a90aa98c | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE | Medical Group Care LLC | f4a9d879-4736-4f63-e053-2995a90adeba | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de66240-441c-00ad-e063-6294a90a4a05 | 2025-09-03 | Warnings | M012 |
| MGC Health | COUGH DROPS ASSORTED CITRUS VITAMIN C | Medical Group Care LLC | ff99c57a-e06a-69d3-e053-6394a90a6775 | 2025-09-03 | Warnings | M012 |
| DISCOUNT DRUG MART | COUGH DROPS VITAMIN C SUGAR-FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3de7ace0-e389-b751-e063-6394a90ab4e9 | 2025-09-03 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution | PSN | 164b2559-2d3f-431e-a03c-07e86731af5c | 9 |
| 1043400 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SCD | 164b2559-2d3f-431e-a03c-07e86731af5c | 9 |
| 1043400 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution | SY | 164b2559-2d3f-431e-a03c-07e86731af5c | 9 |
| 1043400 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution | SY | 164b2559-2d3f-431e-a03c-07e86731af5c | 9 |
| 1043400 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution | SY | 164b2559-2d3f-431e-a03c-07e86731af5c | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 21130-044-08 | 21130004408 | 237 mL in 1 BOTTLE, PLASTIC (21130-044-08) | 237 ml | 2014-06-30 | 0000-00-00 | No | No | Current |
| 21130-044-12 | 21130004412 | 355 mL in 1 BOTTLE (21130-044-12) | 355 ml | 2014-06-30 | 0000-00-00 | No | No | Current |