FDA.reportPublic FDA data

Ivarest

Product NDC
10157-9077
11-digit product format
101579077
Labeler code
10157
Product ID
10157-9077_3f9296ee-f86d-4ca4-922d-1b6926de869d
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Benzyl Alcohol, and Diphenhydramine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Blistex Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-12-31
Substance
BENZYL ALCOHOL; DIPHENHYDRAMINE HYDROCHLORIDE; ZINC OXIDE
Active strength
10.5; 2; 14 g/100g; g/100g; g/100g
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ivarest
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZYL ALCOHOL10.5 g/100g
DIPHENHYDRAMINE HYDROCHLORIDE2 g/100g
ZINC OXIDE14 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLKG8494WBH, TC2D6JAD40, SOI2LOH54Z
Rxcui1298467

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298467calamine 14 % / benzyl alcohol 10.5 % / diphenhydrAMINE HCl 2 % Topical CreamPSN6f68cbbb-6269-4bb3-8cc9-50b146703b423
1298467benzyl alcohol 0.105 ML/ML / calamine 140 MG/ML / diphenhydramine hydrochloride 20 MG/ML Topical CreamSCD6f68cbbb-6269-4bb3-8cc9-50b146703b423
1298467benzyl alcohol 10.5 % / calamine 14 % / diphenhydramine hydrochloride 2 % Topical CreamSY6f68cbbb-6269-4bb3-8cc9-50b146703b423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10157-9077-1101579077011 TUBE in 1 CARTON (10157-9077-1) / 56 g in 1 TUBE1 tube2007-12-310000-00-00NoNoCurrent