Kidkare

Product NDC
0536-2310
11-digit product format
005362310
Labeler code
0536
Product ID
0536-2310_93640944-8e90-d456-e053-2995a90ac9fe
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine, Dextromethorphan Hydrobromide, and Pseudoephedrine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Rugby Laboratories, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-01-13
Marketing end
2020-09-30
Substance
CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
1 mg/5mL; mg/5mL; mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-2310DDiscontinued by firm2026-10-15
excluded packagepackage0536-23100536-2310-97DDiscontinued by firm2026-10-15

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-2310-97d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-2310-97f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-2310-972ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-2310-97a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-2310-97cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-2310-97cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-2310-97302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-2310-97ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-2310-970efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-2310-97ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-2310-97367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-2310-97557ba5c1ecfa…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
0536-2310-97ML - Milliliter0536-231099d52e82-2cf1-4739-80af-abeccc1c285812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ChlorpheniramineACTIVE INGREDIENT3U6IO1965UKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
ChlorpheniramineACTIVE MOIETY3U6IO1965UKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
DextromethorphanACTIVE MOIETY7355X3ROTSKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
PseudoephedrineACTIVE MOIETY7CUC9DDI9FKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
Anhydrous Trisodium CitrateINACTIVE INGREDIENTRS7A450LGAKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
CherryINACTIVE INGREDIENTBUC5I9595WKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
FD&C Red no. 40INACTIVE INGREDIENTWZB9127XOAKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
Propylene glycolINACTIVE INGREDIENT6DC9Q167V3KIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RKIDKARE (CHLORPHENIRAMINE, DEXTROMETHORPHAN HYDROBROMIDE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [RUGBY LABORATORIES, INC.]1