Baza Protect

Product NDC: 11701-082
11-digit product format: 117010082
Labeler code: 11701
Product ID: 11701-082_7819db44-465c-4283-81fd-5f1bfd6ee11f
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide and Dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: Coloplast Corp
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-04-06
Substance: ZINC OXIDE; DIMETHICONE, UNSPECIFIED
Active strength: 120; 10 mg/g; mg/g
Pharmacologic classes: Skin Barrier Activity [PE]
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 · 20 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
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11701-082-24	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11701-082-22	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11701-082-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11701-082-24	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11701-082-22	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11701-082-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
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	11701-082-24	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11701-082-22	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11701-082-03	`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	11701-082-24	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11701-082-22	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11701-082-03	`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	11701-082-24	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11701-082-22	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11701-082-03	`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: Baza Protect
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	120 mg/g
DIMETHICONE, UNSPECIFIED	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
637565	Internal RxNorm lookup
1053158	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
256dfcfc-a91c-49b0-9439-452586a0880e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
11701-082-03	2024-10-03	Baza ® Protect
11701-082-22	2024-10-03	Baza ® Protect
11701-082-24	2024-10-03	Baza ® Protect
11701-082-03	2023-01-30	Baza ® Protect
11701-082-22	2023-01-30	Baza ® Protect
11701-082-24	2023-01-30	Baza ® Protect

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11701-082-03	Baza Protect	57 g in 1 TUBE	CREAM	57	3
11701-082-22	Baza Protect	4 g in 1 PACKET	CREAM	4	3
11701-082-24	Baza Protect	142 g in 1 TUBE	CREAM	142	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11701-082-03	GM - Gram	11701-082	4646efbc-6072-49bc-aa13-1793008ea1f4	1	2023-09-05
11701-082-24	GM - Gram	11701-082	a2fd9979-dee0-4f93-b7a3-a3b9742a74cc	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11701-082	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	2	Current NDC, Legacy NDC, 3 package rows	20241004_256dfcfc-a91c-49b0-9439-452586a0880e.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 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EELHOE Cuticle Pusher Pen	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	52c7f956-a2a1-ae1d-e063-6294a90ab3c2	2026-05-27	Warnings	Exact identifier application number: M016
Dermoia Eczema Relief Colloidal Oatmeal	OATMEAL	Treasurewise LLC	1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a	2026-05-27	Warnings	Exact identifier application number: M016
Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Wal-Mart Stores, Inc.	61e76e2a-fc46-7a64-e053-2991aa0a56a8	2026-05-26	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Wal-Mart Stores, Inc.	61929c97-bd6b-0d7c-e053-2991aa0aa571	2026-05-26	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Pharma Nobis, LLC	fbcfa541-beda-06de-e053-6294a90a9298	2026-05-26	Warnings	Exact identifier application number: M016
Humco Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Humco holding Group, Inc.	f7dcd959-fb98-43bb-8dd3-a662bf8a053c	2026-05-26	Warnings	Exact identifier application number: M016
Advanced Healing	PETROLATUM	CVS Pharamacy, Inc	0bd3380e-2284-44a7-b2ef-68c9909627fd	2026-05-26	Warnings, Adverse reactions	Exact identifier application number: M016
CeraVe Developed with Dermatologists Healing Lip Balm	PETROLATUM	L'Oreal USA Products Inc	21dc8842-0672-4d46-bcea-b8e3d54c48bf	2026-05-20	Warnings	Exact identifier application number: M016
AFTER CARE	DIMETHICONE	Merz North America	c19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae	2026-05-20	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Trifecta Pharmaceuticals USA	63b551fc-7d16-c099-e053-2a91aa0a5f2c	2026-05-18	Warnings	Exact identifier application number: M016
ADVANCED SILICONE SCAR	ALLANTOIN	Yantai Aien Biotechnology Co., Ltd.	51ffdc45-5acf-ae20-e063-6294a90a55e8	2026-05-17	Warnings	Exact identifier application number: M016
LCFateLC Nail Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	51ea23f4-0a23-4ae1-e063-6394a90aa051	2026-05-16	Warnings	Exact identifier application number: M016
Radlive Active Defense Nano-Silver Cream	COLLOIDAL OATMEAL	SilverCeuticals	51e23135-008d-9db5-e063-6294a90a7d61	2026-05-15	Warnings	Exact identifier application number: M016
Cerave Developed with Dermatologists Healing	PETROLATUM	LOreal USA Products Inc	de44ac01-ba17-4f97-ac12-9ea348013bde	2026-05-14	Warnings	Exact identifier application number: M016
Triple 3x Max Diaper Rash	ZINC OXIDE	Advantice Health, LLC	e554046b-cd0a-4a6e-8f24-2e610c697432	2026-05-14	Warnings	Exact identifier application number: M016
Eczema Therapy	COLLOIDAL OATMEAL	SilverCeuticals	3a26a35e-a098-0e22-e063-6294a90a96b9	2026-05-13	Warnings	Exact identifier application number: M016
Nail- Pflaster	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	519681bc-6312-f627-e063-6394a90a2845	2026-05-11	Warnings	Exact identifier application number: M016
Hydrating	PETROLATUM	Aldermed Inc.	4aa6a354-e487-4b65-e063-6394a90abbf0	2026-05-09	Warnings	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Aldermed Inc.	4aa79292-dc91-b538-e063-6294a90ac3f0	2026-05-09	Warnings	Exact identifier application number: M016
XIMONTH Nail Fungus Care Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	514a998d-aa2a-46b6-e063-6294a90a6c22	2026-05-08	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1053158	Baza Protect 1 % / 12 % Topical Cream	PSN	256dfcfc-a91c-49b0-9439-452586a0880e	3
637565	dimethicone 1 % / zinc oxide 12 % Topical Cream	PSN	256dfcfc-a91c-49b0-9439-452586a0880e	3
1053158	dimethicone 10 MG/ML / zinc oxide 120 MG/ML Topical Cream [Baza-Protect]	SBD	256dfcfc-a91c-49b0-9439-452586a0880e	3
637565	dimethicone 10 MG/ML / zinc oxide 120 MG/ML Topical Cream	SCD	256dfcfc-a91c-49b0-9439-452586a0880e	3
1053158	Baza Protect (dimethicone 1 % / zinc oxide 12 % ) Topical Cream	SY	256dfcfc-a91c-49b0-9439-452586a0880e	3
637565	dimethicone 1 % / zinc oxide 12 % Topical Cream	SY	256dfcfc-a91c-49b0-9439-452586a0880e	3
637565	dimethicone 10 MG/ML / ZNO 120 MG/ML Topical Cream	SY	256dfcfc-a91c-49b0-9439-452586a0880e	3
1053158	dimethicone 10 MG/ML / ZNO 120 MG/ML Topical Cream [Baza-Protect]	SY	256dfcfc-a91c-49b0-9439-452586a0880e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11701-082-03	11701008203	57 g in 1 TUBE (11701-082-03)	57 g	2020-04-06	0000-00-00	No	No	Current
11701-082-22	11701008222	4 g in 1 PACKET (11701-082-22)	4 g	2020-04-06	0000-00-00	No	No	Current
11701-082-24	11701008224	142 g in 1 TUBE (11701-082-24)	142 g	2020-04-06	0000-00-00	No	No	Current