Cold and Flu
- Product NDC
- 0363-0566
- 11-digit product format
- 003630566
- Labeler code
- 0363
- Product ID
- 0363-0566_d8d36729-c04b-4753-8ec1-a630d6a16113
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-08-16
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cold and Flu
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
| DOXYLAMINE SUCCINATE | 12.5 mg/30mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2 |
| Rxcui | 1043400 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0363-0566-34 | Cold and Flu | 237 mL in 1 BOTTLE | SOLUTION | 237 | | 12 |
| 0363-0566-40 | Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | | 12 |
| 0363-0566-43 | Cold and Flu | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 12 |
| 0363-0566-50 | Cold and Flu | 2 in 1 PACKAGE | SOLUTION | 2 | | 12 |
| 0363-0566-50 | Cold and Flu | 355 mL in 1 BOTTLE | SOLUTION | 355 | | 12 |
| 0363-0566-40 | daytime nighttime cold and flu | 355 mL in 1 BOTTLE | SOLUTION | 355 mL | 650 mg in 30mL | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0363-0566 | COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [WALGREEN COMPANY] | 12 | Current NDC, Legacy NDC, 5 package rows | 20241027_b6d9f421-b236-4660-be7f-85a878f2fc61.zip |
| 0363-0566 | DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [WALGREEN COMPANY] | 4 | Current NDC, Legacy NDC | 20241114_4b49137c-8fc9-43b7-b1a1-82e318237eb6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0363-0566-34 | 00363056634 | 237 mL in 1 BOTTLE (0363-0566-34) | 237 ml | 2012-08-10 | 0000-00-00 | No | No | Current |
| 0363-0566-40 | 00363056640 | 355 mL in 1 BOTTLE (0363-0566-40) | 355 ml | 2011-08-16 | 0000-00-00 | No | No | Current |
| 0363-0566-43 | 00363056643 | 473 mL in 1 BOTTLE | 473 ml | | | | | Historical |
| 0363-0566-50 | 00363056650 | 2 BOTTLE in 1 PACKAGE (0363-0566-50) / 355 mL in 1 BOTTLE | 2 bottle | 2011-08-16 | 0000-00-00 | No | No | Current |