Bruise MD

Product NDC: 69291-9020
Requested package NDC: 69291-9020-1
11-digit product format: 692919020
Labeler code: 69291
Product ID: 69291-9020_edc19f16-e5f4-5f5a-e053-2a95a90a0656
Type: HUMAN OTC DRUG
Nonproprietary name: Allantoin
Dosage form: GEL
Route: TOPICAL
Labeler: Newmedical Technology, Inc.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-01-20
Marketing end: 0000-00-00
Substance: ALLANTOIN
Active strength: 1 g/100g
NDC exclude flag: No
Listing certified through: 2023-12-31
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	69291-9020	69291-9020-1	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 · 11 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…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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
16a2c1cd-ae95-d910-f03d-7e06b11dd243	Product name	5	20260202
653485de-0601-41e4-82db-7a60bb223e27	Product name	1	20251024
23fb3cda-2b50-f3d3-ebde-f542350bd77b	Product name	4	20240828
081b54f0-4545-48b6-b854-03e1401f09ea	Product name	1	20230112
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
aead65a2-216e-4ff8-a178-44aab77c24ed	Product name	1	20180531
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-07-30	486c4a51-9edc-3999-e054-00144ff8d46c
2024-01-30	486c4a51-9edc-3999-e054-00144ff8d46c
2022-03-15	486c4a51-9edc-3999-e054-00144ff8d46c
2022-01-28	486c4a51-9edc-3999-e054-00144ff8d46c
2021-09-10	486c4a51-9edc-3999-e054-00144ff8d46c
2021-07-23	486c4a51-9edc-3999-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69291-9020-1	Bruise MD	1 in 1 CARTON	GEL	1		8
69291-9020-2	Bruise MD	20 g in 1 TUBE	GEL	20		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69291-9020	NEWGEL PLUS SPF (ZINC OXIDE, SUNSCREEN) GEL BRUISE MD (ALLANTOIN) GEL [NEWMEDICAL TECHNOLOGY, INC.]	8	Legacy NDC, 2 package rows	20230609_486c4a51-9edc-3999-e054-00144ff8d46c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
344S277G0Z	ALLANTOIN	97-59-6	ALLANTOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1442087	allantoin 0.5 % Topical Gel	PSN	486c4a51-9edc-3999-e054-00144ff8d46c	8
1442087	allantoin 0.005 MG/MG Topical Gel	SCD	486c4a51-9edc-3999-e054-00144ff8d46c	8
1442087	allantoin 0.5 % Topical Gel	SY	486c4a51-9edc-3999-e054-00144ff8d46c	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69291-9020-1	69291902001	1 TUBE in 1 CARTON (69291-9020-1) > 20 g in 1 TUBE (69291-9020-2)	1 tube	2019-12-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NewGel Plus SPF - Newmedical Technology, Inc.	Newmedical Technology, Inc.	2023-06-08	HUMAN OTC DRUG LABEL	8