FDA.reportPublic FDA data

ARC Skin Protectant

Product NDC
69148-001
11-digit product format
691480001
Labeler code
69148
Product ID
69148-001_8b450573-d048-4077-8c0b-9e0a2e8a72c2
Type
HUMAN OTC DRUG
Nonproprietary name
ALLANTOIN
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Anjon Biologics, Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-06
Substance
ALLANTOIN
Active strength
.5 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ARC Skin Protectant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii344S277G0Z
Rxcui1044541

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69148-001-002024-04-24C16284748780-11030e365-5910-111a-e063-dadaa90a10e2NATURAL CREAM ARC
69148-001-012024-04-24C16284748780-11030e365-5910-111a-e063-dadaa90a10e2NATURAL CREAM ARC
69148-001-002024-01-30C16284748780-11030e365-5910-111a-e063-dadaa90a10e2NATURAL CREAM ARC
69148-001-012024-01-30C16284748780-11030e365-5910-111a-e063-dadaa90a10e2NATURAL CREAM ARC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69148-001-00ARC Skin Protectant118.6 g in 1 TUBEOINTMENT118.66
69148-001-01ARC Skin Protectant60 g in 1 TUBEOINTMENT606
69148-001-02ARC Skin Protectant100 g in 1 TUBEOINTMENT1006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0ZARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
ALLANTOINACTIVE MOIETY344S277G0ZARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
IMIDUREAINACTIVE INGREDIENTM629807ATLARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
SORBITAN TRISTEARATEINACTIVE INGREDIENT6LUM696811ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
VITAMIN AINACTIVE INGREDIENT81G40H8B0TARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69148-001ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC]6Current NDC, Legacy NDC, 3 package rows20240426_f4ff79dd-cb38-4cca-9631-a2758a171873.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044541allantoin 0.5 % Topical OintmentPSNf4ff79dd-cb38-4cca-9631-a2758a1718736
1044541allantoin 0.005 MG/MG Topical OintmentSCDf4ff79dd-cb38-4cca-9631-a2758a1718736
1044541allantoin 0.5 % Topical StickSYf4ff79dd-cb38-4cca-9631-a2758a1718736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69148-001-0069148000100118.6 g in 1 TUBE (69148-001-00) 118.6 g2014-08-060000-00-00NoNoCurrent
69148-001-016914800010160 g in 1 TUBE (69148-001-01) 60 g2018-01-010000-00-00YesNoCurrent
69148-001-0269148000102100 g in 1 TUBE (69148-001-02) 100 g2024-04-22NoNoCurrent