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 27 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eucerin Eczema Relief Body OATMEAL Beiersdorf Inc 9895f3c3-b00b-462c-ace0-696d688e2e04 2025-12-31 Warnings Exact identifier application number: M016 Eucerin Eczema Relief Flare Up Treatment OATMEAL Beiersdorf Inc a9ea4832-3211-40b2-accf-90ace7b9e279 2025-12-31 Warnings Exact identifier application number: M016 Eczema Relief Cream Body Wash OATMEAL Beiersdorf Inc f12644e5-0ff0-de0e-e053-2995a90a0995 2025-12-31 Warnings Exact identifier application number: M016 XIMONTH Honey Eye Drops GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 4727f304-0bc7-2fee-e063-6394a90a0178 2025-12-30 Warnings Exact identifier application number: M016 Kinfield Relief Balm Anti-Itch Remedy KINFIELD RELIEF BALM ANTI-ITCH REMEDY Kinfield, Inc. bf394192-c789-faff-e053-2995a90a52bc 2025-12-30 Warnings Exact identifier application number: M016 911 ALLANTOIN Skinfix, Inc. f28c251e-a91b-4ed4-8224-b47c345f982f 2025-12-29 Warnings Exact identifier application number: M016 EXTRA STRENGTH BODY COLLOIDAL OATMEAL Skinfix, Inc. 32ba5f29-c037-44dd-b5b1-59001ac50753 2025-12-29 Warnings Exact identifier application number: M016 VITACILINA Bebe Diaper Rash ALLANTOIN, ZINC OXIDE Compania Internacional de Comercio, S.A.P.I de C.V. 39726b59-bd85-4541-80e5-4f2919842dca 2025-12-29 Warnings Exact identifier application number: M016 Creamy Diaper Rash ZINC OXIDE Davion, Inc 0fdfe7d3-e4cd-6bea-e063-6394a90a37f6 2025-12-29 Warnings Exact identifier application number: M016 Medicated Cornstarch Baby Powder ACTIVE CORN STARCH Davion, Inc. e39032d1-c8cd-4a41-af10-126970b8ad38 2025-12-29 Warnings Exact identifier application number: M016 WinCo FoodsPetroleum Jelly WHITE PETROLATUM WinCo Foods, LLC f5dcf0b2-4f9f-023a-e053-2995a90a183a 2025-12-28 Warnings Exact identifier application number: M016 WinCo FoodsPetroleum Jelly WHITE PETROLATUM WinCo Foods, LLC f5dca60a-e9bc-4161-e053-2995a90a2bcb 2025-12-28 Warnings Exact identifier application number: M016 Hydrating Healing HYDRATING HEALING OINTMENT Neilmed Pharmaceuticals Inc., 47106abb-4c39-07d9-e063-6394a90a4fae 2025-12-28 Warnings Exact identifier application number: M016 TCX Skincare COLLOIDAL OATMEAL Theraceutix, LLC c3be950b-28cf-47c2-9570-ebd46e43b1ba 2025-12-24 Warnings Exact identifier application number: M016 Nizoral Eczema Relief Cream COLLOIDAL OATMEAL Kramer Laboratories da3a39d7-197f-4451-9d24-f92adbe0fc19 2025-12-23 Warnings Exact identifier application number: M016 Healing Head to Toe ALLANTOIN The Honest Company, Inc dc02033f-8116-1710-e053-2995a90aff69 2025-12-23 Warnings Exact identifier application number: M016 Honest Eczema Cream COLLOIDAL OATMEAL The Honest Company, Inc. 6f111094-425b-4a8c-b71a-5ff65f4a8000 2025-12-23 Warnings Exact identifier application number: M016 BABY ANTI MONKEY BUTT DIAPER RASH ZINC OXIDE, CALAMINE Clarion Brands, LLC e4424d74-f89c-5943-42e8-bf3a38e68619 2025-12-23 Warnings Exact identifier application number: M016 Dissolvable Microneedle Eye Patches ALLANTOIN Advaccine Biopharmaceuticals Suzhou Co., Ltd 4684fa4e-5c5e-045d-e063-6394a90af069 2025-12-22 Warnings Exact identifier application number: M016 Good Neighbor Petroleum Jelly WHITE PETROLATUM AmerisourceBergen e5fb80a0-cc8c-e9e7-e053-2a95a90a455d 2025-12-22 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