Home NDC 56062-056 nitetime
Product NDC 56062-056
11-digit product format 560620056
Labeler code 56062
Product ID 56062-056_9d583684-8de7-4128-9186-6d102e0b8607
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Publix Super Markets Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-02-17
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325; 15; 6.25 mg/1; mg/1; mg/1
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 nitetime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1
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 1094549 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 56062-056-62 nitetime 2 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 2 6 56062-056-62 nitetime 12 in 1 CARTON CAPSULE, LIQUID FILLED 12 6 56062-056-73 nitetime 8 in 1 CARTON CAPSULE, LIQUID FILLED 8 6 56062-056-73 nitetime 2 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 2 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 56062-056 NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [PUBLIX SUPER MARKETS INC] 5 Current NDC, Legacy NDC, 4 package rows 20241017_f681d986-9838-42d8-8ed9-732a39fbf870.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 73 of 178 · 3,551 matching rows.
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 56062-056-62 56062005662 12 BLISTER PACK in 1 CARTON (56062-056-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 12 blister pack 2014-02-24 0000-00-00 No No Current 56062-056-73 56062005673 8 BLISTER PACK in 1 CARTON (56062-056-73) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 8 blister pack 2014-02-17 0000-00-00 No No Current