Home NDC 0904-6465 all nite
Product NDC 0904-6465
11-digit product format 009046465
Labeler code 0904
Product ID 0904-6465_9bfd7bea-ca99-41ae-a92f-4c91ac3327f3
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form SOLUTION
Route ORAL
Labeler Major Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-11-19
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 all nite
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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-6465-09 all nite 237 mL in 1 BOTTLE SOLUTION 237 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6465 ALL NITE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MAJOR PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 1 package rows 20241025_945a4068-3630-4f1d-b794-d2f1603af285.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 71 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CAREALL Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc f3b177ef-55d5-4525-bf33-99205c414a5b 2025-12-22 Warnings Exact identifier application number: M012 CAREALL Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc af2f8389-d696-4060-8abd-6eda04e73009 2025-12-22 Warnings Exact identifier application number: M012 BASIC CARE DAYTIME NIGHTTIME SEVERE COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Amazon.com Services LLC 82e68c65-9898-4106-a2f8-e39d124c703e 2025-12-22 Warnings Exact identifier application number: M012 Nighttime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Harris Teeter, LLC 89fd57d2-fe49-41cb-b02e-9643e526cf47 2025-12-22 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Walgreens 464f6645-ca33-1722-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Walgreen Co. 47f38e79-c730-21b9-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Walgreen Co. 47522852-005a-2a66-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon Cough Drop MENTHOL Walgreens Co, 47653657-80b5-482f-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon Cough Drop MENTHOL Walgreen Co. 47f89d33-6e0a-4bb4-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Strawberry Cough Drop MENTHOL 2.7 MG Walgreen Co. 4766afa8-fdaf-05e5-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 SF Menthol Cough Drop MENTHOL Walgreen Co. 477b9fc3-c3c5-647e-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 SF Honey Lemon Cough Drop MENTHOL Walgreen Co. 477cedee-6bd3-2a34-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE Walgreens Co. 47e0f809-0b30-2b23-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Sugar Free Honey Lemon Cough Drops MENTHOL Walgreen 835e276a-493e-1038-e053-2a91aa0a7ea2 2025-12-21 Warnings Exact identifier application number: M012 Walgreens Mixed Berry Benz-Dex Lozenges BENZOCAINE Walgreen e108731f-6b77-225a-e053-2a95a90ac25c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Walmart Stores Inc. 318e7acb-0ebb-4518-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Walmart Stores Inc. 316968e1-7715-4caa-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon cough drops MENTHOL Walmart Stores Inc. 317bbd33-6087-3af1-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Good Sense Nasal Decongestant PSEUDOEPHEDRINE HCL L. Perrigo Company 455b35b4-3969-411b-8036-887615d71e11 2025-12-21 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Safeway Inc. 4a4f7f82-1b6c-7082-e054-00144ff88e88 2025-12-20 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 0904-6465-09 00904646509 237 mL in 1 BOTTLE (0904-6465-09) 237 ml 2012-11-19 0000-00-00 No No Current