Baza Protect

Product NDC: 11701-046
11-digit product format: 117010046
Labeler code: 11701
Product ID: 11701-046_a888e9dc-9ced-4e46-9aba-6570c65ad11f
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc oxide and Dimethicone
Dosage form: CREAM
Route: TOPICAL
Labeler: Coloplast Corp
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2009-06-15
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 · 24 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
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11701-046-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11701-046-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	11701-046-22	`ad56d346431e…`	`cc804d4bbf1e…`
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	11701-046-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11701-046-23	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	11701-046-22	`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	11701-046-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11701-046-23	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	11701-046-22	`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	11701-046-14	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11701-046-23	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	11701-046-22	`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	11701-046-14	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11701-046-23	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	11701-046-22	`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	11701-046-14	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11701-046-23	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	11701-046-22	`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
ed63df26-3879-46df-8e09-10be569b25be	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
11701-046-14	2024-12-26	Baza ® Protect Skin Protectant Moisture Barrier Cream
11701-046-22	2024-12-26	Baza ® Protect Skin Protectant Moisture Barrier Cream
11701-046-23	2024-12-26	Baza ® Protect Skin Protectant Moisture Barrier Cream
11701-046-14	2023-01-30	Baza ® Protect Skin Protectant Moisture Barrier Cream
11701-046-22	2023-01-30	Baza ® Protect Skin Protectant Moisture Barrier Cream
11701-046-23	2023-01-30	Baza ® Protect Skin Protectant Moisture Barrier Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11701-046-14	Baza Protect	142 g in 1 TUBE	CREAM	142	10
11701-046-22	Baza Protect	4 g in 1 PACKET	CREAM	4	10
11701-046-23	Baza Protect	57 g in 1 TUBE	CREAM	57	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11701-046-14	GM - Gram	11701-046	847abd0e-98eb-494d-b496-6c0e33fd2d2b	1	2012-07-24
11701-046-22	GM - Gram	11701-046	11036513-eb3d-484e-a6da-cb427d921f05	1	2012-07-24
11701-046-23	GM - Gram	11701-046	92ec4e91-3758-476b-bf89-eda39619d724	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
COD LIVER OIL	INACTIVE INGREDIENT	BBL281NWFG	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
EDETIC ACID	INACTIVE INGREDIENT	9G34HU7RV0	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
PEG-40 STEARATE	INACTIVE INGREDIENT	ECU18C66Q7	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
PEG-8 STEARATE	INACTIVE INGREDIENT	2P9L47VI5E	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
QUATERNIUM-15	INACTIVE INGREDIENT	E40U03LEM0	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
TRIACONTANYL PVP (WP-660)	INACTIVE INGREDIENT	N0SS3Q238D	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11701-046	BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20241228_ed63df26-3879-46df-8e09-10be569b25be.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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Gum Therapy Glacier Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ed6889b6-58db-41cf-e053-2a95a90a7de2	2024-11-11	Warnings	Exact identifier application number: M022
Listerine FreshBurst Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	dd3729c2-fd05-4db0-a542-487bb0f9001f	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	9e97e4f8-80c2-44e0-862c-0dfca392a436	2024-11-11	Warnings	Exact identifier application number: M022
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier application number: M022
BIOTENE Fresh Mint Original	SODIUM FLUORIDE	Haleon US Holdings LLC	1101c17f-c848-4cd5-a7cd-679b59dbe1bf	2024-11-05	Warnings	Exact identifier application number: M022
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Cherry	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	a0e145c8-6b08-40be-ae4f-5678c4a78b1e	2024-10-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33b-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Mint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	be57ca56-834f-4170-a407-f193484d8b0a	2024-10-29	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	Warnings	Exact identifier application number: M022

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	ed63df26-3879-46df-8e09-10be569b25be	10
637565	dimethicone 1 % / zinc oxide 12 % Topical Cream	PSN	ed63df26-3879-46df-8e09-10be569b25be	10
1053158	dimethicone 10 MG/ML / zinc oxide 120 MG/ML Topical Cream [Baza-Protect]	SBD	ed63df26-3879-46df-8e09-10be569b25be	10
637565	dimethicone 10 MG/ML / zinc oxide 120 MG/ML Topical Cream	SCD	ed63df26-3879-46df-8e09-10be569b25be	10
1053158	Baza Protect (dimethicone 1 % / zinc oxide 12 % ) Topical Cream	SY	ed63df26-3879-46df-8e09-10be569b25be	10
637565	dimethicone 1 % / zinc oxide 12 % Topical Cream	SY	ed63df26-3879-46df-8e09-10be569b25be	10
637565	dimethicone 10 MG/ML / ZNO 120 MG/ML Topical Cream	SY	ed63df26-3879-46df-8e09-10be569b25be	10
1053158	dimethicone 10 MG/ML / ZNO 120 MG/ML Topical Cream [Baza-Protect]	SY	ed63df26-3879-46df-8e09-10be569b25be	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11701-046-14	11701004614	142 g in 1 TUBE (11701-046-14)	142 g	2009-06-15	0000-00-00	No	No	Current
11701-046-22	11701004622	4 g in 1 PACKET (11701-046-22)	4 g	2009-06-15	0000-00-00	No	No	Current
11701-046-23	11701004623	57 g in 1 TUBE (11701-046-23)	57 g	2009-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Baza ® Protect Skin Protectant Moisture Barrier Cream	Coloplast Corp \| Coloplast Corp. \| Medline Industries, LP	2026-03-31	HUMAN OTC DRUG LABEL	10