HANSHINNOCOL

Product NDC
53153-102
Requested package NDC
53153-102-05
11-digit product format
531530102
Labeler code
53153
Product ID
53153-102_81a833ad-4498-d128-e053-2a91aa0a4cc4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Cholorpheniramine Maleate, Dextromethorphan Hydrobromide
Dosage form
CAPSULE
Route
ORAL
Labeler
Han Kook Shin Yak Pharmaceutical Co., Ltd.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-06-30
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
100 mg/500mg; mg/500mg; mg/500mg
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage53153-10253153-102-05DDiscontinued 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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
CHINESE CINNAMON OILINACTIVE INGREDIENTA4WO0626T5HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
GINGERINACTIVE INGREDIENTC5529G5JPQHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758HHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
JUJUBE FRUITINACTIVE INGREDIENTG55HNL2C70HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
PAEONIA LACTIFLORA ROOTINACTIVE INGREDIENT3Z3866YW6PHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
PUERARIA MONTANA VAR. LOBATA ROOTINACTIVE INGREDIENTPET93F4I3CHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.]5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53153-102-05531530102051 BLISTER PACK in 1 BOX (53153-102-05) > 10 CAPSULE in 1 BLISTER PACK (53153-102-04) > 500 mg in 1 CAPSULE (53153-102-01) 1 blister pack2015-06-300000-00-00NoNoCurrent