Astonea Skin Protectant

Product NDC: 77338-050
11-digit product format: 773380050
Labeler code: 77338
Product ID: 77338-050_1bbb3c29-f7ab-8b08-e063-6294a90a0129
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: ASTONEA LABS PRIVATE LIMITED
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-11-21
Substance: ZINC OXIDE
Active strength: 18 mg/g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-050-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-050-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-050-04	`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: Astonea Skin Protectant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	18 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1044412	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
e3c7a515-3e77-da85-e053-2995a90a3ee1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77338-050-04	2024-06-25	C162847	48780-1	1030e365-1d76-111a-e063-dadaa90a10e2	Astonea skin protectant 1.8% ZNO
77338-050-04	2024-01-30	C162847	48780-1	1030e365-1d76-111a-e063-dadaa90a10e2	Astonea skin protectant 1.8% ZNO

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-050-04	Astonea Skin Protectant	113 g in 1 TUBE	OINTMENT	113		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-050	ASTONEA SKIN PROTECTANT (ZINC OXIDE) OINTMENT [ASTONEA LABS PRIVATE LIMITED]	3	Current NDC, Legacy NDC, 1 package rows	20240627_e3c7a515-3e77-da85-e053-2995a90a3ee1.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 3 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DawnMist White Petrolatum	WHITE PETROLATUM	Dukal LLC	598e9d46-6450-af60-e063-6394a90a3a6b	2026-08-21	Warnings	Exact identifier application number: M016
MUSTELA Diaper Rash 1 2 3	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	163f388e-849d-4b7e-93c1-9045d77a9ec2	2026-08-21	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	0073de92-585d-e01a-e063-6394a90a2ec2	2026-08-21	Warnings	Exact identifier application number: M016
Mederma PM	DIMETHICONE	L Perrigo Company	8c728904-28f4-4333-a9ea-20996fd1b007	2026-08-21	Warnings	Exact identifier application number: M016
Earths Care Hemorrhoid Relief	WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM	DLC Laboratories, Inc.	e860d65b-126d-4d77-8003-9d1381849ab5	2026-08-20	Warnings	Exact identifier application number: M016
ClaraVie	PETROLATUM	Gentell LLC	596987e4-4205-b911-e063-6294a90aa570	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	ZINC OXIDE	Gentell LLC	596abd98-17d7-2a22-e063-6294a90af57d	2026-08-19	Warnings	Exact identifier application number: M016
Claravie Skin Repair Cream	DIMETHICONE	Gentell LLC	596ae269-172e-aef5-e063-6394a90a4e2a	2026-08-19	Warnings	Exact identifier application number: M016
Claravie	LANOLIN	Gentell LLC	596c1b73-e34d-c97d-e063-6394a90ada1b	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	MENTHOL, ZINC OXIDE	Gentell LLC	596c467f-a056-ea78-e063-6394a90a79f2	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	LANOLIN	Gentell LLC	596fe32d-be34-0635-e063-6394a90a2fc0	2026-08-19	Warnings	Exact identifier application number: M016
Medpride	ZINC OXIDE	Shield Line LLC	e2689cae-e347-4c0b-825b-6281a0b7c2f1	2026-08-18	Warnings	Exact identifier application number: M016
Eczema Skin Relief Cream	COLLOIDAL OATMEAL	CVS Health	98fac854-f7b0-4c6e-888d-1bdc6b9323b9	2026-08-17	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	ADUSA Distribution, LLC	5940399c-31e3-6d51-e063-6294a90a8e7c	2026-08-17	Warnings, Adverse reactions	Exact identifier application number: M016
Intimate CareGel	HYALURONIC ACID	Guangzhou Yilong Cosmetics.,Ltd	5918d204-52db-e6d0-e063-6394a90ab78c	2026-08-14	Warnings	Exact identifier application number: M016
TENA Proskin protective cream	ZINC OXIDE	Essity HMS North America Inc.	b840377f-a297-4aff-900e-7ea8b7c98717	2026-08-13	Warnings, Adverse reactions	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	087d66ff-1a8c-dcb2-e063-6294a90a2f8c	2026-08-11	Warnings	Exact identifier application number: M016
Nail Renewal Liquid	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	581f7192-fc17-a706-e063-6394a90a3ffa	2026-08-11	Warnings	Exact identifier application number: M016
Intertrigo Relief Cream	GLYCERIN	Shantou South Moon Biotechnology Co., Ltd.	587220c9-0ae9-3438-e063-6394a90a0a86	2026-08-07	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	The Kroger Co.	9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1044412	zinc oxide 1.8 % Topical Ointment	PSN	e3c7a515-3e77-da85-e053-2995a90a3ee1	3
1044412	zinc oxide 0.018 MG/MG Topical Ointment	SCD	e3c7a515-3e77-da85-e053-2995a90a3ee1	3
1044412	zinc oxide 1.8 % Topical Ointment	SY	e3c7a515-3e77-da85-e053-2995a90a3ee1	3
1044412	ZNO 0.018 MG/MG Topical Ointment	SY	e3c7a515-3e77-da85-e053-2995a90a3ee1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77338-050-04	77338005004	113 g in 1 TUBE (77338-050-04)	113 g	2022-08-17	0000-00-00	No	No	Current