Home NDC 37808-459 night time
Product NDC 37808-459
11-digit product format 378080459
Labeler code 37808
Product ID 37808-459_86e32052-dfce-47ca-9f3c-7f1f0285456e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form SOLUTION
Route ORAL
Labeler H E B
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-04
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 night time
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 37808-459-38 night time 296 mL in 1 BOTTLE SOLUTION 296 8 37808-459-40 night time 355 mL in 1 BOTTLE SOLUTION 355 8 37808-459-50 night time 2 in 1 PACKAGE SOLUTION 2 8 37808-459-50 night time 355 mL in 1 BOTTLE SOLUTION 355 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 ALCOHOL INACTIVE INGREDIENT 3K9958V90M NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3 WATER INACTIVE INGREDIENT 059QF0KO0R NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 37808-459 NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B] 8 Current NDC, Legacy NDC, 4 package rows 20241027_cf31538c-9eee-4c81-80cb-66eecabf0aff.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 37808-459-38 37808045938 296 mL in 1 BOTTLE (37808-459-38) 296 ml 2012-02-04 0000-00-00 No No Current 37808-459-40 37808045940 355 mL in 1 BOTTLE (37808-459-40) 355 ml 2012-07-20 0000-00-00 No No Current 37808-459-50 37808045950 2 BOTTLE in 1 PACKAGE (37808-459-50) > 355 mL in 1 BOTTLE 2 bottle 2012-07-20 0000-00-00 No No Current