Super Max Barrier Cream

Product NDC: 61554-700
Requested package NDC: 61554-700-01
11-digit product format: 615540700
Labeler code: 61554
Product ID: 61554-700_c36a6fd0-bf47-fc28-e053-2a95a90a22d9
Type: HUMAN OTC DRUG
Nonproprietary name: white petroleum, zinc oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: gentell inc
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-11-13
Marketing end: 0000-00-00
Substance: ZINC OXIDE; PETROLATUM
Active strength: 16 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61554-700	61554-700-01	I	Inactivated by FDA		2026-10-05

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 · 7 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
61554-700-01	2025-07-29	C162847	48780-1	f386c649-a6f0-0266-e053-dadaa90a7c1a	Super Max Moisture Barrier Ointment
61554-700-01	2024-10-08	C162847	48780-1	f386c649-a6f0-0266-e053-dadaa90a7c1a	Super Max Moisture Barrier Ointment
61554-700-01	2023-01-30	C162847	48780-1	f386c649-a6f0-0266-e053-dadaa90a7c1a	Super Max Moisture Barrier Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61554-700-01	Super Max Barrier Cream	113.4 g in 1 TUBE	CREAM	113.4		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61554-700	SUPER MAX BARRIER CREAM (WHITE PETROLEUM, ZINC OXIDE) CREAM [GENTELL LLC]	3	Legacy NDC, 1 package rows	20241010_b5599e1b-0cb1-7baa-e053-2a95a90aabeb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61554-700-01	61554070001	113.4 g in 1 TUBE (61554-700-01)	113.4 g	2014-11-13	0000-00-00	No	No	Current