Home NDC 12090-0015 Creomulsion
Product NDC 12090-0015
11-digit product format 120900015
Labeler code 12090
Product ID 12090-0015_3995dad7-8000-675d-e054-00144ff8d46c
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE
Dosage form SYRUP
Route ORAL
Labeler Summit Industries, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2009-12-30
Marketing end 2019-12-31
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 5 mg/5mL
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 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 12090-0015-0 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 12090-0015-0 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 12090-0015-0 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 12090-0015-0 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 12090-0015-0 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 12090-0015-0 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 12090-0015-0 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 12090-0015-0 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 12090-0015-0 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 12090-0015-0 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 12090-0015-0 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 12090-0015-0 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.] 2 CARAMEL INACTIVE INGREDIENT T9D99G2B1R CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.] 2 CORN SYRUP INACTIVE INGREDIENT 9G5L16BK6N CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.] 2 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CREOMULSION FOR CHILDREN (DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [SUMMIT INDUSTRIES, INC.] 2