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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69148-00169148-001-00DDiscontinued by firm2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69148-001-00DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69148-001-00DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69148-001-00DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69148-001-00DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69148-001-00DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69148-001-00DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69148-001-00DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69148-001-00DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69148-001-00DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69148-001-00DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69148-001-00DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69148-001-00DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69148-001-00IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69148-001-01IInactivated by FDA1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1044541Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4ff79dd-cb38-4cca-9631-a2758a171873Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69148-001-002024-04-24NATURAL CREAM ARC
69148-001-012024-04-24NATURAL CREAM ARC
69148-001-002024-01-30NATURAL CREAM ARC
69148-001-012024-01-30NATURAL 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

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 41 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Infection Protection Wound CareALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse98d1d8c-c979-49de-9bd8-cd409efff6de2025-07-11WarningsExact identifier
application number: M016
Neosporin Lip Health Overnight Renewal TherapyPETROLATUMKenvue Brands LLC0da54fe1-c99f-4a2d-9ee5-2dc24005096c2025-07-10WarningsExact identifier
application number: M016
COCOA BUTTER PETROLEUM jellyPETROLATUMSavvy Care & Cosmetics Pvt. Ltd.397d13f1-3b86-3c76-e063-6394a90a0f242025-07-09WarningsExact identifier
application number: M016
Pipette EczemaCOLLOIDAL OATMEALPipette LLC39829827-d801-f5a7-e063-6394a90a024c2025-07-09WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEWestminster Pharmaceuticals, LLC7e045b3a-f33b-4faa-ab9b-2baec6ff79242025-07-08WarningsExact identifier
application number: M016
Desitin Multi-Purpose HealingPETROLATUMKenvue Brands LLC30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab2025-07-07WarningsExact identifier
application number: M016
Astringent SolutionALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEFirst Nation Group065c895c-7d86-f1ed-e063-6394a90a3a522025-07-07WarningsExact identifier
application number: M016
Creamy PetroleumPETROLATUMSavvy Care & Cosmetics Pvt Ltd3916daee-f8d2-e3f0-e063-6294a90a38832025-07-04WarningsExact identifier
application number: M016
Exemax CreamDIMETHICONE, ALLANTOINPureTek Corporation38e79055-df84-d314-e063-6394a90ac95f2025-07-01WarningsExact identifier
application number: M016
Procure Dimethicone 5%DIMETHICONETwin Med LLC38a7e4af-997d-549e-e063-6394a90a0bd62025-06-28WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDerma Sciences Canada Inc.37eff762-1ea9-ec66-e063-6394a90a3d102025-06-19WarningsExact identifier
application number: M016
Dr.Johnes SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLCb731c55e-31ee-429f-8432-fac7c5718d832025-06-18WarningsExact identifier
application number: M016
Dr. Johne SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLC6c5adc3c-9d45-449a-ad42-f9571851cd182025-06-18WarningsExact identifier
application number: M016
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal OatmealOATMEALTHERAPLEX, LLCe51aa467-ffe7-4c6b-8588-6df8592596d42025-06-16WarningsExact identifier
application number: M016
ZIIDII Wild Yam CreamWILD YAMGuangzhou Haishi Biological Technology Co., Ltd.3733154a-4884-9988-e063-6294a90aa78c2025-06-10WarningsExact identifier
application number: M016
Aveeno Calm Plus Restore Skin Therapy BalmCOLLOIDAL OATMEALKenvue Brands LLCdbe7a2cc-9c21-2a48-e053-2a95a90a54e22025-06-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWALGREENS2017113f-d192-5fbb-e063-6294a90a83b02025-05-31WarningsExact identifier
application number: M016
AHHH Bite ReliefSODIUM BICARBONATE7827125a1e070-9228-4ec9-e063-6294a90ad78d2025-05-27WarningsExact identifier
application number: M016
SupreH Bee Venom Skin Tag Treatment LiquidSUPREH BEE VENOM SKIN TAG REMOVER LIQUIDShenzhen Xinxin Yunhai Technology Co., Ltd.35ca9836-917a-b0ac-e063-6294a90a28a22025-05-23WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Bed Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions35d2738c-dacf-7309-e063-6294a90aab4c2025-05-23WarningsExact identifier
application number: M016

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