Home NDC 41250-335 nitetime cold and flu
Product NDC 41250-335
11-digit product format 412500335
Labeler code 41250
Product ID 41250-335_d30b1a85-a76e-486c-b145-cac3cda64450
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form SOLUTION
Route ORAL
Labeler Meijer Distribution Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-09-21
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 nitetime cold and flu
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL DOXYLAMINE SUCCINATE 12.5 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043400 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41250-335-38 nitetime cold and flu 296 mL in 1 BOTTLE SOLUTION 296 9 41250-335-40 nitetime cold and flu 355 mL in 1 BOTTLE SOLUTION 355 9 41250-335-43 nitetime cold and flu 473 mL in 1 BOTTLE SOLUTION 473 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41250-335 NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC] 9 Current NDC, Legacy NDC, 3 package rows 20241218_dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b.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.
Matched openFDA labels page 175 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sinus Pressure plus Pain PE ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE RETAIL BUSINESS SERVICES , LLC. eb64750f-19ac-655f-e053-2995a90a33b5 2023-11-02 Warnings Exact identifier application number: M012 Multi-Symptom Mapap Cold Formula ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL Proficient Rx LP 9bf81b26-38b4-486c-ae89-222119ce1a4f 2023-11-01 Warnings Exact identifier application number: M012 Guaifenesin Syrup and Dextromethorphan GUAIFENESIN SYRUP AND DEXTROMETHORPHAN Natco Pharma USA LLC ad9026f4-f0b6-4d02-aa44-f0460eeefc0e 2023-11-01 Warnings Exact identifier application number: M012 Diphenhydramine HCl Oral Solution DIPHENHYDRAMINE HYDROCHLORIDE Natco Pharma USA LLC 54b64354-ac10-42ff-a53d-96cef933a91a 2023-11-01 Warnings Exact identifier application number: M012 children allergy relief dye free cherry DIPHENHYDRAMINE HCL A-S Medication Solutions 5c6c1809-4c6f-4e8f-a5ae-9796e821d400 2023-11-01 Warnings Exact identifier application number: M012 Daytime and Nighttime Cherry Cold and Flu DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE TARGET CORPORATION 0903b222-1a44-64aa-e063-6294a90abba0 2023-10-31 Warnings Exact identifier application number: M012 Ephrine Nose Drops PHENYLEPHRINE HYDROCHLORIDE Walgreens b620eb9f-2caf-0942-e053-2a95a90ae48e 2023-10-31 Warnings Exact identifier application number: M012 pseudoephedrine hydrochloride PSEUDOEPHEDRINE HCL A-S Medication Solutions 204849d1-ac4b-4dbe-8769-fcb30291f880 2023-10-31 Warnings Exact identifier application number: M012 Daytime Cold and Flu Relief DAYTIME COLD AND FLU RELIEF TopCo Associates, LLC d592fbb8-d4bf-444e-982e-edf6fe97dce4 2023-10-31 Warnings Exact identifier application number: M012 Nite Time Cold and Flu Relief NITE TIME COLD AND FLU RELIEF TopCo Associates, LLC 407dc4ae-882d-4a49-8884-ef048bb404cf 2023-10-31 Warnings Exact identifier application number: M012 12 Hour Original Nasal Decongestant NASAL SPRAY Sheffield Pharmaceuticals LLC cea0ce76-ae75-4484-a7c2-ff1086e9d8b0 2023-10-30 Warnings Exact identifier application number: M012 Mucosa DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Magno-Humphries, Inc. 3a5533fb-1c83-4b95-9cd2-9be663d3ff5f 2023-10-27 Warnings Exact identifier application number: M012 Mucosa Guifenesin GUAIFENESIN Magno-Humphries, Inc. 9d22c208-d0ae-8b6a-e053-2995a90ab90a 2023-10-27 Warnings Exact identifier application number: M012 DG Health Cough Drops Cherry Flavor MENTHOL Dollar General Corporation c7a603d8-72fb-9626-e053-2995a90a09ea 2023-10-26 Warnings Exact identifier application number: M012 Allergy Relief 4 Hour CHLORPHENIRAMINE MALEATE Geri-Care Pharmaceutical Corp 92d90b41-0627-121e-e053-2995a90a2df1 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry MENTHOL Riclan S.A. 8e471265-3594-451a-8921-f0db474abe85 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Eucalyptus MENTHOL Riclan S.A. 1141593a-f3ba-4adf-b332-f9fcb0b5a013 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon MENTHOL Riclan S.A. f6271e85-9ca2-41d3-9bff-a13670ac5b80 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Strawberry MENTHOL Riclan S.A. da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457 2023-10-26 Warnings Exact identifier application number: M012 DG Health Cough Drops Assorted Flavors MENTHOL Dollar General Corporation c731d255-40f2-3cb3-e053-2a95a90a8877 2023-10-26 Warnings Exact identifier application number: M012
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 41250-335-38 41250033538 296 mL in 1 BOTTLE 296 ml Historical 41250-335-40 41250033540 355 mL in 1 BOTTLE (41250-335-40) 355 ml 2012-10-24 0000-00-00 No No Current 41250-335-43 41250033543 473 mL in 1 BOTTLE 473 ml Historical