FDA.reportPublic FDA data

NDC 10157-9077-01 - Ivarest

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
10157-9077
Requested NDC
10157-9077-01
Package NDCs from labels
10157-9077-1, 10157-9077-01
Manufacturer
Blistex Inc
Effective date
2024-07-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ivarest - Blistex IncBlistex Inc2024-07-09HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-9077-1Ivarest1 in 1 CARTONCREAM13
10157-9077-1Ivarest56 g in 1 TUBECREAM563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-9077IVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]3Current NDC, Legacy NDC, 2 package rows20240719_6f68cbbb-6269-4bb3-8cc9-50b146703b42.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzyl AlcoholACTIVE INGREDIENTLKG8494WBHIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40IVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
Benzyl AlcoholACTIVE MOIETYLKG8494WBHIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
DiphenhydramineACTIVE MOIETY8GTS82S83MIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
Zinc OxideACTIVE MOIETYSOI2LOH54ZIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
bentoniteINACTIVE INGREDIENTA3N5ZCN45CIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
benzethonium chlorideINACTIVE INGREDIENTPH41D05744IVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
camphor (synthetic)INACTIVE INGREDIENT5TJD82A1ETIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
D&C red no. 33INACTIVE INGREDIENT9DBA0SBB0LIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
FD&C yellow no. 5INACTIVE INGREDIENTI753WB2F1MIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8IVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (45000 mpa.s at 1%)INACTIVE INGREDIENT86FQE96TZ4IVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HEIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
lanolin oilINACTIVE INGREDIENTOVV5IIJ58FIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
mentholINACTIVE INGREDIENTL7T10EIP3AIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
polyethylene glycol 200INACTIVE INGREDIENTR95B8J264JIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
polyglyceryl-3 diisostearateINACTIVE INGREDIENT46P231IQV8IVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
povidone-iodineINACTIVE INGREDIENT85H0HZU99MIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3IVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
squalaneINACTIVE INGREDIENTGW89575KF9IVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX INC]1
waterINACTIVE INGREDIENT059QF0KO0RIVAREST (ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [BLISTEX 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 2 of 461 · 9,204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
unii: TC2D6JAD40
ClaravieALUMINUM HYDROXIDE GELGentell LLC5afea757-8feb-f907-e063-6394a90a62592026-09-08WarningsExact identifier
application number: M016
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
Intense Therapy Lip Balm Mango and MandarinSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8c55d1cd-cdd6-468b-8a17-b940c62101162026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intensive Therapy Lip Balm Mango Chili LimeAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC51349d57-b14d-4798-8d68-03fbe3713d1e2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Sun Guard Sunscreen SPF45SUNSCREENJack Black, LLC3cc86bb2-05ce-47eb-8c71-f4f116ca58402026-09-08WarningsExact identifier
unii: SOI2LOH54Z
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea ButterLIP BALM SUNSCREENJack Black, LLC518cb17a-fdaa-4a60-93fc-708305366eb82026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Lavender Lip Balm 0.25ozLIP BALM SUNSCREENJack Black, L.L.C.e8c6a6d9-1093-41f1-87d5-faf8583d43192026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: TC2D6JAD40
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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