Home NDC 53153-101-05 HANSHINNOCOL
Product NDC 53153-101
Requested package NDC 53153-101-05
11-digit product format 531530101
Labeler code 53153
Product ID 53153-101_81a833ad-44a2-d128-e053-2a91aa0a4cc4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Cholorpheniramine Maleate, Dextromethorphan Hydrobromide
Dosage form LIQUID
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 200 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 CHINESE CINNAMON OIL INACTIVE INGREDIENT A4WO0626T5 HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 GINGER INACTIVE INGREDIENT C5529G5JPQ HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 GLYCYRRHIZA GLABRA INACTIVE INGREDIENT 2788Z9758H HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 JUJUBE FRUIT INACTIVE INGREDIENT G55HNL2C70 HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 MONOSODIUM GLUTAMATE INACTIVE INGREDIENT W81N5U6R6U HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 PAEONIA LACTIFLORA ROOT INACTIVE INGREDIENT 3Z3866YW6P HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 PUERARIA MONTANA VAR. LOBATA ROOT INACTIVE INGREDIENT PET93F4I3C HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 SUCROSE INACTIVE INGREDIENT C151H8M554 HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3 water INACTIVE INGREDIENT 059QF0KO0R HANSHINNOCOL (ACETAMINOPHEN, CHOLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HAN KOOK SHIN YAK PHARMACEUTICAL CO., LTD.] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53153-101-05 53153010105 10 BOX in 1 CARTON (53153-101-05) > 3 BOTTLE in 1 BOX (53153-101-04) > 30 mL in 1 BOTTLE (53153-101-01) 10 box 2015-06-30 0000-00-00 No No Current