Astonea

Product NDC: 77338-307
11-digit product format: 773380307
Labeler code: 77338
Product ID: 77338-307_1bbb6d64-77d3-86e2-e063-6294a90abdc4
Type: HUMAN OTC DRUG
Nonproprietary name: White Petrolatum
Dosage form: OINTMENT
Route: TOPICAL
Labeler: ASTONEA LABS PRIVATE LIMITED
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-05-23
Substance: PETROLATUM
Active strength: 76 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	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	77338-307-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-307-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-307-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	77338-307-04	`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	77338-307-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-307-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-307-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	77338-307-04	`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	77338-307-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-307-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-307-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	77338-307-04	`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
Brand name suffix: Vitamin A and D
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PETROLATUM	76 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049072	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
ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	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, Related label table
NDC	Effective	Related label
77338-307-02	2024-06-25	VITAMIN A&D
77338-307-03	2024-06-25	VITAMIN A&D
77338-307-04	2024-06-25	VITAMIN A&D
77338-307-05	2024-06-25	VITAMIN A&D
77338-307-02	2024-01-30	VITAMIN A&D
77338-307-03	2024-01-30	VITAMIN A&D
77338-307-04	2024-01-30	VITAMIN A&D
77338-307-05	2024-01-30	VITAMIN A&D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77338-307-02	AstoneaVitamin A and D	5 g in 1 PACKET	OINTMENT	5	2
77338-307-03	AstoneaVitamin A and D	28.3 g in 1 TUBE	OINTMENT	28.3	2
77338-307-04	AstoneaVitamin A and D	113 g in 1 TUBE	OINTMENT	113	2
77338-307-05	AstoneaVitamin A and D	425 g in 1 JAR	OINTMENT	425	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-307	ASTONEA VITAMIN A AND D (WHITE PETROLATUM) OINTMENT [ASTONEA LABS PRIVATE LIMITED]	2	Current NDC, Legacy NDC, 4 package rows	20240627_ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf.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 8 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zinc Oxide 20%	ZINC OXIDE	Trifecta Pharmaceuticals USA	8cbe9b1f-fec0-9579-e053-2995a90ac461	2026-06-22	Warnings	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Walmart Inc.	e294a871-ae73-4a4f-89a3-9ebf0b4fd03a	2026-06-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash Cream	ZINC OXIDE	Foshan Desha Biotechnology Co., Ltd.	5487ad62-3d73-042e-e063-6394a90afe8c	2026-06-18	Warnings	Exact identifier application number: M016
Baby HealingOintment	PETROLATUM	Foshan Desha Biotechnology Co., Ltd.	5488b81a-e5fe-1452-e063-6394a90a2ae4	2026-06-18	Warnings	Exact identifier application number: M016
Baby Eczema Moisturizing Cream	COLLOIDAL OATMEAL	Foshan Desha Biotechnology Co., Ltd.	548a0c34-6aac-14f7-e063-6394a90ae652	2026-06-18	Warnings	Exact identifier application number: M016
Jell with Vitamin A D	LANOLIN, PETROLATUM	Jell Pharmaceuticals Pvt Ltd.	d976e5f0-1be5-d9c4-e053-2a95a90a44a4	2026-06-17	Warnings	Exact identifier application number: M016
Dove	ANTIBACTERIAL CARE BEAUTY BAR	Conopco d/b/a Unilever	547472cf-4902-584e-e063-6294a90a28ac	2026-06-17	Warnings	Exact identifier application number: M016
Dr Sosnowskis Chafing Hero Severe Chafing Balm	LANOLIN	Herstat (USA) Inc.	389041a8-7316-b38e-e063-6294a90a3e8e	2026-06-17	Warnings	Exact identifier application number: M016
Drs. Pharmacy Creamy Cocoa Butter Petroleum Jelly	WHITE PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	546749e3-70c5-10e8-e063-6294a90ad8c4	2026-06-16	Warnings	Exact identifier application number: M016
Drs. Pharmacy Creamy Petroleum Jelly	WHITE PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	54698388-f9e8-c470-e063-6394a90a783b	2026-06-16	Warnings	Exact identifier application number: M016
Medline	ZINC OXIDE	Medline Industries, LP	3c319953-04fc-87a8-e063-6294a90a5058	2026-06-15	Warnings	Exact identifier application number: M016
Calamine, Pramoxind HCl	CALAMINE, PRAMOXIND HCL	H E B	4a7a0b09-d9bc-e752-e063-6394a90a9f2c	2026-06-15	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine, Zinc Oxide	CALAMINE, ZINC OXIDE	H E B	4a79259e-64ac-d187-e063-6294a90a78db	2026-06-15	Warnings, Adverse reactions	Exact identifier application number: M016
HEALMUSZ HEALTHY FEET	UREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEET	Jiangxi Yudexi Pharmaceutical Co., LTD	4a34b6de-03ec-3be4-e063-6294a90afb52	2026-06-14	Warnings	Exact identifier application number: M016
PUVIDA SNOW BLEACH	NIACINAMIDE 15% SNOW BLEACH	Jiangxi Yudexi Pharmaceutical Co., LTD	4a48ebbd-7c80-1bce-e063-6294a90ab4ae	2026-06-14	Warnings	Exact identifier application number: M016
XIMONTH Foot Shoe Deodorizer	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	541d9ce9-62ad-847e-e063-6394a90a55e0	2026-06-13	Warnings	Exact identifier application number: M016
Skin Protectant with 33% Petrolatum Advance Moisturizing Cream	PETROLATUM	Aldermed Inc.	87413149-d39f-4f8a-b1c9-6de5eb37ff7e	2026-06-12	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE, WHITE PETROLATUM	Aldermed Inc.	54154a72-27ad-7bfa-e063-6394a90a4eca	2026-06-12	Warnings	Exact identifier application number: M016
Circletong Tag Wart Remover Patches	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	541b0fe9-f900-8191-e063-6394a90af321	2026-06-12	Warnings	Exact identifier application number: M016
Baby Butz	ZINC OXIDE	Olen Skin Care Corporation	e6be6b62-13a4-410d-b8ac-457b58fd23da	2026-06-10	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049072	petrolatum 76 % Topical Ointment	PSN	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2
1049072	petrolatum 0.76 MG/MG Topical Ointment	SCD	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2
1049072	petrolatum 76 % Topical Ointment	SY	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77338-307-02	77338030702	5 g in 1 PACKET (77338-307-02)	5 g	2013-05-23	0000-00-00	No	No	Current
77338-307-03	77338030703	28.3 g in 1 TUBE (77338-307-03)	28.3 g	2013-05-23	0000-00-00	No	No	Current
77338-307-04	77338030704	113 g in 1 TUBE (77338-307-04)	113 g	2013-05-23	0000-00-00	No	No	Current
77338-307-05	77338030705	425 g in 1 JAR (77338-307-05)	425 g	2013-05-23	0000-00-00	No	No	Current