FDA.reportPublic FDA data

NDC 53153-102-01 - HANSHINNOCOL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53153-102
Requested NDC
53153-102-01
Package NDCs from labels
53153-102-01, 53153-102-04, 53153-102-05
Manufacturer
Han Kook Shin Yak Pharmaceutical Co., Ltd.
Effective date
2019-02-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HANSHINNOCOL CAPSULEHan Kook Shin Yak Pharmaceutical Co., Ltd.2019-02-11HUMAN OTC DRUG LABEL

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 23 of 209 · 4,166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Regular StrengthACETAMINOPHENCVS PHARMACY5e35df92-6282-4ca6-902b-bb6bd326b4872026-06-23WarningsExact identifier
unii: 362O9ITL9D
Broncolito ChildrenDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509f5b72-9894-ef44-e063-6394a90a6d072026-06-23WarningsExact identifier
unii: 9D2RTI9KYH
equaline daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI9a199782-5d7e-449b-a86c-969746f0e96f2026-06-23WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Company542b9861-8055-45f6-8cbf-9fe5cde1c4d92026-06-23WarningsExact identifier
unii: 9D2RTI9KYH
unii: V1Q0O9OJ9Z
Pain RelieverACETAMINOPHENOrelli Inc.4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d2026-06-22WarningsExact identifier
unii: 362O9ITL9D
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEDr. Reddy's Labratories Inc.79be4527-73b4-93b2-5858-1e2a9819fd502026-06-22Warnings, Adverse reactionsExact identifier
unii: 9D2RTI9KYH
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)bfec14d5-d9ce-4b9c-a803-3d01cb00b56c2026-06-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC5f1aaa8e-c65f-43b3-9850-c60c1663d78f2026-06-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a2026-06-22WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack1c793d37-cbc9-4d76-a84a-d076b51011432026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Pain ReliefACETAMINOPHENDOLGENCORP, LLCacc94a3e-21b6-4375-9881-38cf9bab86922026-06-19WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Multi-Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBRKROGER COMPANY30d4c4b9-0f5f-0279-e063-6394a90af1b52026-06-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI490766e7-1781-4b2b-a8f4-d4efb9fff5602026-06-19WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Extra Strength TYLENOL Cold plus Flu Multi Symptom DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC5487b2e1-b0e5-0236-e063-6394a90a3a8b2026-06-18WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEDOLGENCORP, LLCe1e24d52-0b4d-400b-8181-e3f6ab75c4f62026-06-18WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack8ad0df84-e3f6-4c1d-b791-c8467eb984aa2026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
CHILDRENS 12 HR COUGH RELIEFDEXTROMETHORPHAN POLISTIREXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED380d7f6d-cdfe-4a22-a6e0-13fe2ae12e6c2026-06-17WarningsExact identifier
unii: 9D2RTI9KYH
dg health 8 hr arthritis pain reliefACETAMINOPHENDolgencorp Incfc7838a7-fc6d-41b7-b8e4-97bee2bfa6d42026-06-17WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENOncor Pharmaceuticals4c396d0e-aa93-4f9e-b065-2e606f7f05cd2026-06-17WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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