Home NDC 50066-601 Tukol Maxium Strength Cough and Mucus Relief
Product NDC 50066-601
11-digit product format 500660601
Labeler code 50066
Product ID 50066-601_fa673d33-89b9-40b9-adc3-6c0c6ca420e8
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Genomma Lab USA, Inc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-03-17
Marketing end 0000-00-00
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10 mg/1; mg/1
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 · 42 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50066-601-02 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50066-601-02 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50066-601-02 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50066-601-02 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50066-601-02 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50066-601-02 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50066-601-02 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50066-601-02 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50066-601-02 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50066-601-02 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50066-601-02 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50066-601-02 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50066-601-02 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50066-601-02 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50066-601-02 1332a3947898…d4bfe170f9cd…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 50066-601-02 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 50066-601-02 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 50066-601-02 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50066-601-02 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 50066-601-02 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 50066-601-02 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 50066-601-02 Tukol Maxium Strength Cough and Mucus Relief 1 in 1 BLISTER PACK CAPSULE, GELATIN COATED 1 1 50066-601-02 Tukol Maxium Strength Cough and Mucus Relief 20 in 1 CARTON CAPSULE, GELATIN COATED 20 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50066-601 TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC] 1 Legacy NDC, 2 package rows 20150317_ae5ce270-ca7b-4a6e-bc48-547e97db06e1.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50066-601-02 50066060102 1 in 1 BLISTER PACK Historical