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: 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 · 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: 2027-12-31

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 67 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EltaMD Laser Balm	PETROLATUM SKIN PROTECTANT	CP Skin Health Group, Inc	1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb	2023-11-09	Warnings	Exact identifier application number: M016
DiaperDerm Diaper Rash	ZINC OXIDE	Diaperderm Inc	4e1fce3e-c2b7-42da-9953-1dbb13e2467c	2023-11-06	Warnings	Exact identifier application number: M016
Doctors Diaper Rash Cream	ZINC OXIDE	DOCTOR'S DIAPER RASH CREAM, INC	0988ccb1-7881-4d97-bcbf-d0cf4316e4be	2023-11-06	Warnings	Exact identifier application number: M016
DERMOIA Manuka Honey Eczema Cream	OATMEAL	TREASUREWISE LLC	a48e52a3-b681-4489-a1fd-6b09d8bc9c55	2023-11-06	Warnings	Exact identifier application number: M016
GL HEALTH Barrier Skin Protectant	ZINC OXIDE	GL HEALTH, INC.	76cfa330-fea9-48d4-b187-469154765d39	2023-11-06	Warnings	Exact identifier application number: M016
Skin-lube	PETROLATUM, DIMETHICONE	The Hygenic Company, LLC.	d1005dec-04f6-3f88-e053-2a95a90ad9cb	2023-11-05	Warnings	Exact identifier application number: M016
Dr. Sheffield Anti Itch Cream	ANTI ITCH CREAM	Sheffield Pharmaceuticals LLC	77f0593e-f694-4c02-9fd9-ad56ff2a920c	2023-10-30	Warnings	Exact identifier application number: M016
calahist	CALAMINE AND PRAMOXINE HYDROCHLORIDE	WALGREEN COMPANY	fed45e06-cc53-fbc5-e053-6294a90a1b19	2023-10-27	Warnings	Exact identifier application number: M016
calahist clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	WALGREEN COMPANY	fed469c2-fe13-6726-e053-6394a90a5f51	2023-10-27	Warnings	Exact identifier application number: M016
Dr. Sayman Salve	SALVE	Sheffield Pharmaceuticals LLC	18bdcd0c-9c81-47e1-ae24-2239ff8fd066	2023-10-24	Warnings	Exact identifier application number: M016
Theriac Advanced Healing	LANOLIN	Sheffield Pharmaceuticals LLC	c780cd27-dc9e-45f3-97f0-e59b1b6b955a	2023-10-24	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	d66e369e-9b19-b084-e053-2995a90aa259	2023-10-23	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Healing	COLLOIDAL OATMEAL	Babo Botanicals, Inc.	08659a5c-2d10-2f98-e063-6394a90a7760	2023-10-23	Warnings	Exact identifier application number: M016
White Rose Petroleum Jelly	PETROLATUM	J. Strickland & Co.	1aeb090d-c103-4c2e-accc-d9d248315db9	2023-10-21	Warnings	Exact identifier application number: M016
Tricalm Hydrogel	ALUMINUM ACETATE	MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES	082c6441-be47-4466-e063-6394a90ad500	2023-10-20	Warnings	Exact identifier application number: M016
Empower	WHITE PETROLATUM, ZINC OXIDE	Bemis Manufacturing Company Inc	08006b60-966b-155b-e063-6294a90a206a	2023-10-18	Warnings	Exact identifier application number: M016
ANUBISMED	HA HYALURONIC	ANUBIS COSMETICS SL	eac771e2-4c1b-3808-e053-2995a90ac5fc	2023-09-05	Warnings	Exact identifier application number: M016
AnubisMed	SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA	ANUBIS COSMETICS SL	ebf4b3ab-34e1-185a-e053-2a95a90ace3a	2023-09-05	Warnings	Exact identifier application number: M016
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE	ANUBIS COSMETICS SL	f22b212d-d21d-5984-e053-2995a90a683e	2023-09-01	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