FDA.reportPublic FDA data

CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD

Product NDC
0031-2238
Requested package NDC
0031-2238-13
11-digit product format
000312238
Labeler code
0031
Product ID
0031-2238_2c43f7e0-968f-4fc9-809f-d53f3ea5a278
Type
HUMAN OTC DRUG
Nonproprietary name
chlorpheniramine maleate, dextromethorphan HBr
Dosage form
SOLUTION
Route
ORAL
Labeler
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2005-03-04
Marketing end
0000-00-00
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
2 mg/10mL; mg/10mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0031-22380031-2238-13DDiscontinued by firm2026-10-12

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-2238-13ML - Milliliter0031-22385e4cf6f6-7a84-441b-9ed0-1a8b9237931b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9ZCHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) LIQUID [RICHMOND DIVISION OF WYETH]1
dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYHCHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) LIQUID [RICHMOND DIVISION OF WYETH]1
chlorpheniramineACTIVE MOIETY3U6IO1965UCHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) LIQUID [RICHMOND DIVISION OF WYETH]1
dextromethorphanACTIVE MOIETY7355X3ROTSCHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) LIQUID [RICHMOND DIVISION OF WYETH]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-2238-13000312238131 BOTTLE in 1 CARTON (0031-2238-13) > 118 mL in 1 BOTTLE1 bottle2005-03-040000-00-00NoNoCurrent