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: 2027-12-31

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 58 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
insect bite relief 01	MENTHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd.	006e457d-bfcd-791a-e063-6294a90a8d66	2024-09-23	Warnings	Exact identifier application number: M016
dabur	ZINC OXIDE	Dabur India Limited	22cd1e7a-5448-b3f6-e063-6394a90a880d	2024-09-23	Warnings	Exact identifier application number: M016
DABUR Vitamin A and D	WHITE PETROLATUM	Dabur India Limited	22cd44ef-4b02-604d-e063-6394a90a7a0a	2024-09-23	Warnings	Exact identifier application number: M016
DABUR ZINC OXIDE 3.8%	ZINC OXIDE	Dabur India Limited	2290bbe2-8a88-b94e-e063-6294a90a7e38	2024-09-20	Warnings	Exact identifier application number: M016
Aveeno Baby Daily Moisture	DIMETHICONE	Kenvue Brands LLC	b34c8e71-7fad-484c-b387-3c424f50b743	2024-09-19	Warnings	Exact identifier application number: M016
Evereden Intensive Eczema Balm	COLLOIDAL OATMEAL	Eden Brands Inc.	2243d4ca-5ca4-54d0-e063-6394a90a3940	2024-09-16	Warnings	Exact identifier application number: M016
Whipped Gel	COLLOIDAL OATMEAL	OCEAN OLIVE LLC	222b381c-665e-177d-e063-6394a90a3306	2024-09-15	Warnings	Exact identifier application number: M016
BioBarrier Renewal Cream	ALLANTOIN	bluemercury	1ee15f84-0561-3cd2-e063-6394a90ab68e	2024-09-15	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Strategic Sourcing Services, LLC	22173332-9d09-768c-e063-6394a90a94e1	2024-09-14	Warnings	Exact identifier application number: M016
Diaper Rash Cream 5.6oz	ZINC OXIDE	China Ningbo Shangge Cosmetics Technology Corp.	21a7c4ce-1360-931c-e063-6294a90aa66d	2024-09-11	Warnings	Exact identifier application number: M016
Healing Cream 3oz	PETROLATUM	China Ningbo Shangge Cosmetics Technology Corp.	21bdbb13-cc64-b5d7-e063-6294a90ae3fd	2024-09-11	Warnings	Exact identifier application number: M016
Healing Cream15oz	PETROLATUM	Rejoice International Corp.	21e4026c-d3da-e4f7-e063-6394a90aabed	2024-09-11	Warnings	Exact identifier application number: M016
Baby Balm Stick 0.65oz	PETROLATUM OINTMENT	China Ningbo Shangge Cosmetics Technology Corp.	21c0b614-ea19-e98d-e063-6294a90ac44e	2024-09-10	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Moisturizing Fragrance Free	DIMETHICONE	Kenvue Brands LLC	65476a2a-8cd4-4477-ac27-9a06f41e4711	2024-09-09	Warnings	Exact identifier application number: M016
Diaper Rash Cream 15oz	ZINC OXIDE	Rejoice International Corp.	213213ab-f935-a62e-e063-6394a90af96b	2024-09-03	Warnings	Exact identifier application number: M016
Diaper Rash Cream 5.6oz	ZINC OXIDE	Rejoice International Corp.	2133876b-eaf0-f988-e063-6394a90aae4d	2024-09-03	Warnings	Exact identifier application number: M016
Baby Balm Stick 0.65oz	PETROLATUM	Rejoice International Corp.	20cf3bb8-4ab8-2980-e063-6294a90ad631	2024-08-29	Warnings	Exact identifier application number: M016
SUDOCREM SKIN PROTECTANT	ZINC OXIDE	LEDA INNOVATIONS USA, INC.	20d2cf0b-d237-fd78-e063-6394a90a8d03	2024-08-29	Warnings	Exact identifier application number: M016
Healing Cream 3oz	PETROLATUM	Rejoice International Corp.	20c9b964-c9af-d63a-e063-6294a90ab979	2024-08-28	Warnings	Exact identifier application number: M016
Babyganics Soothing Itch	OATMEAL	KAS Direct, LLC	5c2806fb-5af4-4532-b31a-be77bb23b277	2024-08-28	Warnings	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