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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69148-001	69148-001-00	D	Discontinued by firm		2026-10-21

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f4ff79dd-cb38-4cca-9631-a2758a171873	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69148-001-00	2024-04-24	NATURAL CREAM ARC
69148-001-01	2024-04-24	NATURAL CREAM ARC
69148-001-00	2024-01-30	NATURAL CREAM ARC
69148-001-01	2024-01-30	NATURAL CREAM ARC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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
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 64 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Itch Relief	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	CVS Pharmacy	c60cfbf2-6788-43dc-b23a-e3433b7f3265	2023-12-20	Warnings	Exact identifier application number: M016
Sunmark Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	c7467f21-56cc-43ca-abfa-e62d35c8baa6	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	08c00c1a-7ec8-4624-9db0-a0e8430cd126	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Caldyphen Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services LLC	329cd4ef-b699-46ff-a5d6-907f7c327c03	2023-12-19	Warnings	Exact identifier application number: M016
DDM Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d536077-b5c6-29b8-e053-2a91aa0a9ae1	2023-12-19	Warnings	Exact identifier application number: M016
Sunmark Phenolated Calamine	CALAMINE AND ZINC OXIDE AND PHENOL	Strategic Sourcing Services LLC	8e68efc4-4c95-41c0-9fed-32297b1b2edc	2023-12-19	Warnings	Exact identifier application number: M016
Calm and Heal Melting Balm	ALLANTOIN	The Honest Company, Inc.	b08a1bd6-986d-9520-e053-2995a90a865e	2023-12-19	Warnings	Exact identifier application number: M016
TopCare Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE LOTION	TOPCO ASSOCIATES LLC	8dced3ea-147b-3d46-e053-2a95a90aa1c0	2023-12-18	Warnings	Exact identifier application number: M016
TopCare Calamine	CALAMINE 8% AND ZINC OXIDE 8% LOTION	TOPCO ASSOCIATES LLC	8dcf134e-0427-0c43-e053-2995a90a7c26	2023-12-18	Warnings	Exact identifier application number: M016
HEB Calaclear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	H E B	5d576794-88d1-484a-e053-2991aa0aa479	2023-12-18	Warnings	Exact identifier application number: M016
Publix Calamine Medicated	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Publix	5d6ba4cf-f2cb-0ecb-e053-2991aa0a5673	2023-12-18	Warnings	Exact identifier application number: M016
TopCare Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	TOPCO ASSOCIATES LLC	8dce8817-b905-4064-e053-2995a90a071e	2023-12-18	Warnings	Exact identifier application number: M016
Assured Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Greenbriar International	9d378cc5-9af0-1389-e053-2995a90a0b96	2023-12-18	Warnings	Exact identifier application number: M016
HEB Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	H E B	5d579680-6bcb-1161-e053-2991aa0aead1	2023-12-18	Warnings	Exact identifier application number: M016
Publix Clear Anti-Itch	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Publix	5d6b905f-ed30-1ab7-e053-2a91aa0a816b	2023-12-18	Warnings	Exact identifier application number: M016
Humco Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Humco Holding Group, Inc.	5fca3a73-6d66-496b-bd33-6e044f9039bc	2023-12-15	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Humco Holding Group, Inc	a3816729-be2b-4b4f-a609-953576cd2e3b	2023-12-15	Warnings	Exact identifier application number: M016
Humco Mineral Oil Light	MINERAL OIL	Humco Holding Group, Inc.	753f35c3-1420-4817-ba63-b737a9c99a1d	2023-12-15	Warnings	Exact identifier application number: M016
Humco Witch Hazel	WITCH HAZEL	Humco Holding Group, Inc.	3cf07016-a129-49ca-8fad-b67dda5aa009	2023-12-15	Warnings	Exact identifier application number: M016
Rite Aid Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Rite Aid Corporation	5df71189-9b36-9dee-e053-2a91aa0a9e49	2023-12-15	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
344S277G0Z	ALLANTOIN	97-59-6	ALLANTOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1044541	allantoin 0.5 % Topical Ointment	PSN	f4ff79dd-cb38-4cca-9631-a2758a171873	6
1044541	allantoin 0.005 MG/MG Topical Ointment	SCD	f4ff79dd-cb38-4cca-9631-a2758a171873	6
1044541	allantoin 0.5 % Topical Stick	SY	f4ff79dd-cb38-4cca-9631-a2758a171873	6

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