Night Time Cold and Flu
- Product NDC
- 49580-0343
- 11-digit product format
- 495800343
- Labeler code
- 49580
- Product ID
- 49580-0343_6b8c5604-2fc0-4acb-a71e-0a9ae331fd4e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- P & L Development, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-10-31
- Marketing end
- 2026-12-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Night Time Cold and Flu
- Brand name suffix
- ReadyInCase
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 |
|---|
| 49580-0343-2 | Night Time Cold and FluReadyInCase | 355 mL in 1 BOTTLE, PLASTIC | LIQUID | 355 | | 13 |
| 49580-0343-4 | Night Time Cold and FluReadyInCase | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | | 13 |
| 49580-0343-6 | Night Time Cold and FluReadyInCase | 177 mL in 1 BOTTLE, PLASTIC | LIQUID | 177 | | 13 |
| 49580-0343-8 | Night Time Cold and FluReadyInCase | 237 mL in 1 BOTTLE, PLASTIC | LIQUID | 237 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| DOXYLAMINE SUCCINATE | ACTIVE INGREDIENT | V9BI9B5YI2 | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| DOXYLAMINE | ACTIVE MOIETY | 95QB77JKPL | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [AARON INDUSTRIES INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49580-0343 | NIGHT TIME COLD AND FLU READYINCASE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [P & L DEVELOPMENT, LLC] | 11 | Current NDC, Legacy NDC, 4 package rows | 20241211_e7dd763b-3005-4723-933b-171eb772afee.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 |
|---|
| 49580-0343-2 | 49580034302 | 355 mL in 1 BOTTLE, PLASTIC (49580-0343-2) | 355 ml | 2014-10-31 | 2026-12-31 | No | No | Current |
| 49580-0343-4 | 49580034304 | 118 mL in 1 BOTTLE, PLASTIC (49580-0343-4) | 118 ml | 2014-10-31 | 2026-12-31 | No | No | Current |
| 49580-0343-6 | 49580034306 | 177 mL in 1 BOTTLE, PLASTIC (49580-0343-6) | 177 ml | 2014-10-31 | 2026-12-31 | No | No | Current |
| 49580-0343-8 | 49580034308 | 237 mL in 1 BOTTLE, PLASTIC (49580-0343-8) | 237 ml | 2014-10-31 | 2026-12-31 | No | No | Current |