Home NDC 50066-303 Tukol Honey Nighttime Cold and Flu
Product NDC 50066-303
11-digit product format 500660303
Labeler code 50066
Product ID 50066-303_24fec102-30d8-373f-e063-6394a90ac8ab
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE
Dosage form SYRUP
Route ORAL
Labeler Genomma Lab USA
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-02-09
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 21.667; 1; .4167 mg/mL; mg/mL; mg/mL
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 2026-12-31
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50066-303-04 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50066-303-04 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50066-303-04 bd6a592717d7…303034d00443…
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 Tukol Honey Nighttime Cold and Flu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 21.667 mg/mL DEXTROMETHORPHAN HYDROBROMIDE 1 mg/mL DOXYLAMINE SUCCINATE .4167 mg/mL
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50066-303-04 Tukol Honey Nighttime Cold and Flu 1 in 1 CARTON SYRUP 1 9 50066-303-04 Tukol Honey Nighttime Cold and Flu 118 mL in 1 BOTTLE, PLASTIC SYRUP 118 9 50066-303-04 Tukol Honey Daytime and Nighttime Value Pack 118 mL in 1 BOTTLE, PLASTIC SYRUP 118 mL 0.4167 mg in 1mL 8 50066-303-04 Tukol Honey Daytime and Nighttime Value Pack 1 in 1 CARTON SYRUP 21.667 mg in 1mL 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50066-303 TUKOL HONEY NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) SYRUP [GENOMMA LAB USA] 9 Current NDC, Legacy NDC, 2 package rows 20241023_bf25f38e-3549-4f78-be90-46605b5f2c11.zip 50066-303 TUKOL HONEY DAYTIME AND NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [GENOMMA LAB USA] 8 Current NDC, Legacy NDC 20241024_bccc11d2-d227-4cbb-b0fc-ac6abb6dce57.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 177 · 3,534 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50066-303-04 50066030304 1 BOTTLE, PLASTIC in 1 CARTON (50066-303-04) / 118 mL in 1 BOTTLE, PLASTIC 2020-02-09 0000-00-00 No No Current