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 15 of 209 · 4,166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProlateOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENForte Bio-Pharma LLC9d75ad3b-bc9b-0c22-e053-2a95a90ac71e2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENHikma Pharmaceuticals USA Inc.995a6cc7-8b72-4d35-b3b4-8c5752438fb72026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
unii: V1Q0O9OJ9Z
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsExact identifier
unii: 362O9ITL9D
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
unii: 9D2RTI9KYH
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
unii: 9D2RTI9KYH
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
unii: 362O9ITL9D
OXYCODONE AND ACETAMINOPHENOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSpecGx LLCf2137f1a-b49a-40bd-97ac-cd6b36e295f42026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Pain Relief Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporation17d27771-a112-474f-9a58-29af0d7e1af32026-07-27WarningsExact identifier
unii: 362O9ITL9D
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Infants TYLENOLACETAMINOPHENKenvue Brands LLC2143cc16-86db-4060-96da-5c228ae9207b2026-07-24WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENSoftgel Healthcare Pvt Ltd352bb451-ffdc-411a-e063-6294a90a8cf52026-07-24WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
unii: 9D2RTI9KYH
unii: 362O9ITL9D
Feverall InfantsACETAMINOPHENSun Pharmaceutical Industries, Inc.3ade895b-5dca-4d81-9415-8091923162ff2026-07-24WarningsExact identifier
unii: 362O9ITL9D
acetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.fdb7331a-d029-8b2a-e053-6294a90adfcd2026-07-24WarningsExact identifier
unii: 362O9ITL9D
Childrens Pain and FeverACETAMINOPHENAurohealth LLC5ada044e-50e8-4874-ac04-df5f1f9e735d2026-07-24WarningsExact identifier
unii: 362O9ITL9D
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporationa63727c3-64d8-4ae9-8da3-974cae6beed22026-07-24WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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