HANSHINNOCOL

Product NDC
53153-102
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53153-102DDiscontinued by firm2026-10-12
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 · 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 packagepackage53153-102-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53153-102-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53153-102-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53153-102-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53153-102-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53153-102-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53153-102-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53153-102-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53153-102-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53153-102-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53153-102-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53153-102-05557ba5c1ecfa…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