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 1 of 79 · 1,573 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pharmacys Prescription 4.5 OZ Creamy Petroleum JellyWHITE PETROLATUMAmerican Consumer Products Corp.5c3eb6b1-d570-0b4c-e063-6394a90af4622026-09-24WarningsExact identifier
unii: 4T6H12BN9U
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: 4T6H12BN9U
unii: 88AYB867L5
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Black Tea and BlackberryLIP BALM SUNSCREENJack Black, LLC172a70bc-8a09-4258-b9bf-cf3c67ff76132026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Cucumber LimeSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC5f15bee9-9bf4-4f27-a6b5-4205deb625f62026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm Vanilla BourbonAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC517040d1-e6ed-40ca-a46f-2f75403dbc3c2026-09-08WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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