Home NDC 50066-536 Tukol A
Product NDC 50066-536
11-digit product format 500660536
Labeler code 50066
Product ID 50066-536_158e568c-c1da-4e77-a6a4-34062f86f1fc
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form LIQUID
Route ORAL
Labeler Genomma Lab USA, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-06-09
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 5; 50; 2.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Tukol A
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL GUAIFENESIN 50 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1370205 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 50066-536-24 Tukol A 118 mL in 1 BOTTLE LIQUID 118 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50066-536 TUKOL A (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE ) LIQUID [GENOMMA LAB USA, INC.] 4 Current NDC, Legacy NDC, 1 package rows 20180101_651f0d7c-c76b-434d-95fd-427609b40b46.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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tukol A DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Genomma Lab USA, Inc. 651f0d7c-c76b-434d-95fd-427609b40b46 2017-12-28 Warnings Exact identifier ndc (product): 50066-536
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 50066-536-24 50066053624 118 mL in 1 BOTTLE (50066-536-24) 118 ml 2014-06-09 0000-00-00 No No Current