Home NDC 63824-599-16 Mucinex Fast-Max
Product NDC 63824-599
Requested package NDC 63824-599-16
11-digit product format 638240599
Labeler code 63824
Product ID 63824-599_0f3010aa-8e70-4465-a1bf-6c0bbfbe7020
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler RB Health (US) LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-11-27
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 2020-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 63824-599-16 Mucinex Fast-Max Congestion and Headache 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 4 63824-599-16 Mucinex Fast-Max Congestion and Headache 8 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 8 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 Dextromethorphan hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 Phenylephrine hydrochloride ACTIVE INGREDIENT 04JA59TNSJ MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 Dextromethorphan ACTIVE MOIETY 7355X3ROTS MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 Phenylephrine ACTIVE MOIETY 1WS297W6MV MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 gelatin INACTIVE INGREDIENT 2G86QN327L MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 lecithin, soybean INACTIVE INGREDIENT 1DI56QDM62 MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 mineral oil INACTIVE INGREDIENT T5L8T28FGP MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 povidones INACTIVE INGREDIENT FZ989GH94E MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 sorbitol INACTIVE INGREDIENT 506T60A25R MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1 water INACTIVE INGREDIENT 059QF0KO0R MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-599 MUCINEX FAST-MAX CONGESTION AND HEADACHE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RB HEALTH (US) LLC] 4 Legacy NDC, 2 package rows 20191010_3d59587e-8f28-40d5-9b1b-2aebd50a148f.zip
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 63824-599-16 63824059916 2 BLISTER PACK in 1 CARTON (63824-599-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2015-11-27 0000-00-00 No No Current