Home NDC 69148-001 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 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69148-001-00 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 69148-001-00 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 69148-001-00 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 69148-001-00 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 69148-001-00 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 69148-001-00 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 69148-001-00 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 69148-001-00 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 69148-001-00 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 69148-001-00 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 69148-001-00 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 69148-001-00 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69148-001-00 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69148-001-01 I Inactivated by FDA 1332a3947898…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 Ingredient Strength ALLANTOIN .5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 344S277G0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1044541 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69148-001-00 ARC Skin Protectant 118.6 g in 1 TUBE OINTMENT 118.6 6 69148-001-01 ARC Skin Protectant 60 g in 1 TUBE OINTMENT 60 6 69148-001-02 ARC Skin Protectant 100 g in 1 TUBE OINTMENT 100 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALLANTOIN ACTIVE INGREDIENT 344S277G0Z ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 ALLANTOIN ACTIVE MOIETY 344S277G0Z ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 COCONUT OIL INACTIVE INGREDIENT Q9L0O73W7L ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 IMIDUREA INACTIVE INGREDIENT M629807ATL ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 JOJOBA OIL INACTIVE INGREDIENT 724GKU717M ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 SHEA BUTTER INACTIVE INGREDIENT K49155WL9Y ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 SORBITAN TRISTEARATE INACTIVE INGREDIENT 6LUM696811 ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 VITAMIN A INACTIVE INGREDIENT 81G40H8B0T ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69148-001 ARC SKIN PROTECTANT (ALLANTOIN) OINTMENT [ANJON BIOLOGICS, INC] 6 Current NDC, Legacy NDC, 3 package rows 20240426_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 51 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Copperlife Foot DIMETHICONE 1% Tommie Copper, Inc. cb825d2c-6333-3c1f-e053-2995a90a78f3 2024-12-15 Warnings Exact identifier application number: M016 Tommie Copper Foot DIMETHICONE 1% Tommie Copper, Inc. ca3d3374-a3d4-69e5-e053-2995a90a3ece 2024-12-15 Warnings Exact identifier application number: M016 Evereden Healing Eczema Treatment COLLOIDAL OATMEAL Eden Brands, Inc. d43f0eaa-aab0-eaff-e053-2995a90ac5c8 2024-12-13 Warnings Exact identifier application number: M016 Babo Fragrance Free Diaper Cream ZINC OXIDE Babo Botanicals, Inc. adcd4fc7-c400-fc8e-e053-2a95a90a7e1f 2024-12-12 Warnings Exact identifier application number: M016 Domeboro ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE Advantice Health, LLC. 28c39200-2f7c-954b-3ce7-7349b2738812 2024-12-12 Warnings Exact identifier application number: M016 Atopis Eczema Therapy Cream COLLOIDAL OATMEAL Bionona Limited 8d4b4a14-b631-f2fa-e053-2a95a90a932f 2024-12-12 Warnings Exact identifier application number: M016 Desitin Daily Defense Zinc Oxide Diaper Rash ZINC OXIDE Kenvue Brands LLC b6e0d1a3-e469-4102-916b-d5cc8ca12e73 2024-12-11 Warnings Exact identifier application number: M016 Little Me Multipurpose Baby Balm WHITE PETROLATUM Shalom International Corp e09518f1-3691-4d85-a8e1-a5c452057066 2024-12-11 Warnings Exact identifier application number: M016 Blistex Ivarest Poison Ivy Itch ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE Blistex Inc. e1eaa3e7-12ab-4b7b-b1b0-77ab07b76a2a 2024-12-11 Warnings Exact identifier application number: M016 Deep Renewal Broad Spectrum DIMETHICONE, AVOBENZONE, HOMOSALATE, AND OCTISALATE Blistex Inc 11c0e084-dc40-4969-a176-3af4116d6f27 2024-12-10 Warnings Exact identifier application number: M016 BOA VIDA Recovery Creme DIMETHICONE Central Solutions Inc bfa07058-7a20-4b9f-bad1-4b9fb5c037e0 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Canopy DIMETHICONE Central Solutions Inc 44c98a3f-02f1-46ae-9fb0-1eb822b5ceaf 2024-12-09 Warnings Exact identifier application number: M016 DermaCen Skin Protectant ZINC OXIDE Central Solutions Inc 990c3a65-bca5-1f0d-e053-2995a90aa7ae 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Calvida ZINC OXIDE Central Solutions Inc 48eb2031-bc80-45d5-b8b3-cc08fcab64f1 2024-12-09 Warnings Exact identifier application number: M016 BOA VIDA Cleansing DIMETHICONE Central Solutions Inc 0b456b20-ab06-4adf-b5f0-1693d33979df 2024-12-09 Warnings Exact identifier application number: M016 SOOTHE Sensitive Skin Treatment ALLANTOIN, DIMETHICONE Rodan & Fields 2bd8cac4-5f40-4d04-91f2-3ea8a138033b 2024-12-09 Warnings Exact identifier application number: M016 Aveeno Eczema Therapy Rescue Relief Treatment COLLOIDAL OATMEAL Kenvue Brands LLC f67e528a-b822-3f7a-e053-2995a90ae733 2024-12-06 Warnings Exact identifier application number: M016 Humphreys Maravilla WITCH HAZEL Humphreys Pharmacal, Incorporated 7d403bf4-8a0d-4337-8e81-1149cd0ae1dc 2024-12-06 Warnings Exact identifier application number: M016 Skin Soothing Cream COLLOIDAL OATMEAL Allure Labs Inc 9b1dfb4b-ce35-46a1-bfc6-ee5b871955f3 2024-12-05 Warnings Exact identifier application number: M016 Skin Soothing Cream - Nut Free COLLOIDAL OATMEAL Allure Labs b5eb48a5-e884-3bf6-e053-2a95a90abb97 2024-12-05 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69148-001-00 69148000100 118.6 g in 1 TUBE (69148-001-00) 118.6 g 2014-08-06 0000-00-00 No No Current 69148-001-01 69148000101 60 g in 1 TUBE (69148-001-01) 60 g 2018-01-01 0000-00-00 Yes No Current 69148-001-02 69148000102 100 g in 1 TUBE (69148-001-02) 100 g 2024-04-22 No No Current