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 40 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EIGHT HOUR SKIN FRAGRANCE FREE	PETROLATUM	REVLON	b61d6e2e-18dd-37d2-e053-2a95a90af57b	2025-08-01	Warnings	Exact identifier application number: M016
Vigority Wild Yam Cream	ESTRIOL CREAM	FOUNDATION COMMERCE INC	39b2bef7-46c5-9ad5-e063-6294a90ae983	2025-07-30	Warnings	Exact identifier application number: M016
Rugby Caldyphen Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Rugby Laboratories	9af3a740-ef97-26ce-e053-2a95a90a0ee1	2025-07-28	Warnings	Exact identifier application number: M016
Aveeno Baby Eczema Therapy Soothing Bath Treatment	OATMEAL	Kenvue Brands LLC	e7eb10b7-3950-49cb-ba73-11e7581b6be9	2025-07-25	Warnings	Exact identifier application number: M016
ProCure SkinGuard	PETROLATUM 49.9%	Twin Med LLC	3a1721f6-1bb0-cd47-e063-6394a90a148e	2025-07-25	Warnings	Exact identifier application number: M016
ProCure HydroCerin	PETROLATUM 33%	Twin Med LLC	3ab7248d-b914-9fdd-e063-6294a90ac4c8	2025-07-24	Warnings	Exact identifier application number: M016
AD PREVENT Original	AD PREVENT ORIGINAL	WellSpring Pharmaceutical Corporation	cf73246e-81c1-42e9-a107-dc6c99cf7d01	2025-07-24	Warnings	Exact identifier application number: M016
Dimethicone 1 Skin Protectant	DIMETHICONE	Universal Distribution Center LLC	2c5b96b9-24d6-4223-a63d-fe83d7c02368	2025-07-24	Warnings	Exact identifier application number: M016
Dr Butlers Soothing Incontinence	MINERAL OIL 59.8%, PETROLATUM 36.0%	Beyond Health PA	3a9d3796-fd05-fe57-e063-6294a90a0ac6	2025-07-23	Warnings	Exact identifier application number: M016
A and D plus E	VITAMIN A, D AND E OINTMENT	Derma Sciences Canada Inc.	35aca592-bfd0-652f-e063-6394a90ac53e	2025-07-22	Warnings	Exact identifier application number: M016
Petroleum Jelly	PETROLATUM	Derma Sciences Canada Inc.	3a895e6c-da8d-db9b-e063-6394a90ace40	2025-07-22	Warnings	Exact identifier application number: M016
Petroleum Jelly	PETROLEUM JELLY	NeilMed Pharmaceuticals Inc.	36bbbb1e-78e9-98f6-e063-6294a90a66d1	2025-07-21	Warnings	Exact identifier application number: M016
Mountain Ice Eczema	COLLOIDAL OATMEAL	Mountainside Medical Equipment, Inc.	1a91f33e-dd85-4d5a-b61c-e460a507e292	2025-07-21	Warnings	Exact identifier application number: M016
Our Eczema Remedy	COLLOIDAL OATMEAL	Fewer Better Things	3a755b4c-47c8-9ca5-e063-6394a90af84a	2025-07-21	Warnings	Exact identifier application number: M016
Aveeno DAILY MOISTURIZING	DIMETHICONE	Kenvue Brands LLC	54a13b85-32b5-439d-a27a-8fba2cf44251	2025-07-16	Warnings	Exact identifier application number: M016
ProCure Moisture Barrier	1% DIMETHICONE, 12% ZINC OXIDE	Twin Med LLC	3988c83b-d4eb-1f09-e063-6394a90a45ad	2025-07-14	Warnings	Exact identifier application number: M016
Avalon Organics Antidandruff Conditioner	SALICYLIC ACID	The Hain Celestial Group, Inc.	66db1071-022a-aa19-e053-2a91aa0a8e39	2025-07-11	Warnings	Exact identifier application number: M016
Avalon Organics Antidandruff	SALICYLIC ACID	The Hain Celestial Group, Inc.	66c7f730-64f3-4eef-e053-2a91aa0a4225	2025-07-11	Warnings	Exact identifier application number: M016
terrasil Infection Protection Wound Care Maximum Strength	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	9e7843e2-ca69-40f5-a4ce-da6b03ebe7f7	2025-07-11	Warnings	Exact identifier application number: M016
terrasil Skin Repair	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	92a23c7f-6b89-49cb-93e2-49ab7a85c86d	2025-07-11	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