FDA.reportPublic FDA data

NDC 0145-0630-61 - Sarna

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
0145-0630
Requested NDC
0145-0630-61
Package NDCs from labels
0145-0630-05, 0145-0630-61, 0145-0630-62
Manufacturer
Stiefel Laboratories, Inc | KIK HOLDCO COMPANY INC.
Effective date
2019-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsStiefel Laboratories, Inc | KIK HOLDCO COMPANY INC.2019-01-23HUMAN OTC DRUG LABEL
Drug FactsPhysicians Total Care, Inc.2012-09-11HUMAN OTC DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0145-0630-05ML - Milliliter0145-0630b58bce68-b736-4603-a605-ab9d800e105212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
PRAMOXINEACTIVE MOIETY068X84E056SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27ESARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5ESARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
WATERINACTIVE INGREDIENT059QF0KO0RSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [STIEFEL LABORATORIES, INC]8
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
PRAMOXINEACTIVE MOIETY068X84E056SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ESARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999RSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
POLYOXYL 8 STEARATEINACTIVE INGREDIENT2P9L47VI5ESARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSARNA (PRAMOXINE HYDROCHLORIDE) LOTION [PHYSICIANS TOTAL CARE, INC.]1

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 4 of 79 · 1,566 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
unii: 92RU3N3Y1O
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
HyVee Ultra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc49808dc8-a26e-49f4-e063-6294a90a47962026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
HyVee Extra Strength Gas Relief SOFTGELSIMETHICONEHyVee Inc496dd780-fe7c-ced6-e063-6294a90aa5982026-08-21WarningsExact identifier
unii: 92RU3N3Y1O
0.9% Benzyl Alcohol Solution (Laboratory Use Only)0.9% BENZYL ALCOHOL SOLUTION (LABORATORY USE ONLY)Guangzhou Huanmei Cosmetics Co., Ltd5976bde6-0999-ffc4-e063-6394a90aadcf2026-08-20WarningsExact identifier
unii: LKG8494WBH
Mag-AL PlusALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEPAI Holdings, LLC dba PAI Pharma896ab07a-1b40-43ab-8589-3be86b1c41982026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsExact identifier
unii: 92RU3N3Y1O
First Aid Antibiotic and Burn ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEAmazon.com Services LLC3459a453-0a94-4122-adad-bb120daecd9e2026-08-18WarningsExact identifier
unii: 88AYB867L5
CVS Health Anti gasSIMETHICONECVS PHARMACY352b1d0e-c6dc-491e-b3e2-c3d9dac3213b2026-08-17WarningsExact identifier
unii: 92RU3N3Y1O
CVS Health Infant Gas ReliefSIMETHICONECVS PHARMACY088993c1-31f0-4270-a3df-a585e7c8d5112026-08-17WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Fall Harvest Collection Spiced Apple CiderCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a6040ff-1779-3215-e063-6294a90aaab12026-08-15WarningsExact identifier
unii: 92RU3N3Y1O
Mylanta Fall Harvest Collection Pumpkin SpiceCALCIUM CARBONATE,MAGNESIUM HYDROXIDE AND SIMETHICONEInfirst Healthcare Inc.5a60a221-5b37-806e-e063-6394a90a5ccc2026-08-15WarningsExact identifier
unii: 92RU3N3Y1O
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
CVS PHARMACY Extra Strength Gas ReliefSIMETHICONE ANTIGASCVSb0fc2f24-cd63-4bb2-b9bb-a73449bcc1692026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Extra StrengthSIMETHICONECVS98db6216-897c-4cf6-a4b7-b913ae3a24962026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
CVS PHARMACY Gas reliefSIMETHICONECVSc2a3a978-c957-4453-88b3-53f4e80a24652026-08-13WarningsExact identifier
unii: 92RU3N3Y1O
triple antibiotic pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyf0fa2822-02a2-49e5-ad47-aa7e9cc2da712026-08-11WarningsExact identifier
unii: 88AYB867L5
WinCo FOODS Extra Strength Gas ReliefSIMETHICONEWINCO FOODS, LLCe2caf17a-a807-47f6-ab85-8e15a4679db42026-08-07WarningsExact identifier
unii: 92RU3N3Y1O
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy46921bea-fcbe-94d6-e063-6394a90a726b2026-08-07WarningsExact identifier
unii: 88AYB867L5

Reported adverse events (FAERS/openFDA)#

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