FDA.reportPublic FDA data

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
DIMETHICONE, UNSPECIFIED; ZINC OXIDE
Active strength
10; 120 mg/g; mg/g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baza Protect
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED10 mg/g
ZINC OXIDE120 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, SOI2LOH54Z
Rxcui637565, 1053158

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11701-082-032024-10-03C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect
11701-082-222024-10-03C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect
11701-082-242024-10-03C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect
11701-082-032023-01-30C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect
11701-082-222023-01-30C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect
11701-082-242023-01-30C16284748780-1f386c649-c3a4-0266-e053-dadaa90a7c1aBaza ® Protect

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11701-082-03Baza Protect57 g in 1 TUBECREAM573
11701-082-22Baza Protect4 g in 1 PACKETCREAM43
11701-082-24Baza Protect142 g in 1 TUBECREAM1423

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11701-082-03GM - Gram11701-0824646efbc-6072-49bc-aa13-1793008ea1f412023-09-05
11701-082-24GM - Gram11701-082a2fd9979-dee0-4f93-b7a3-a3b9742a74cc12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11701-082BAZA PROTECT (ZINC OXIDE AND DIMETHICONE) CREAM [COLOPLAST MANUFACTURING US, LLC]2Current NDC, Legacy NDC, 3 package rows20241004_256dfcfc-a91c-49b0-9439-452586a0880e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053158Baza Protect 1 % / 12 % Topical CreamPSN256dfcfc-a91c-49b0-9439-452586a0880e3
637565dimethicone 1 % / zinc oxide 12 % Topical CreamPSN256dfcfc-a91c-49b0-9439-452586a0880e3
1053158dimethicone 10 MG/ML / zinc oxide 120 MG/ML Topical Cream [Baza-Protect]SBD256dfcfc-a91c-49b0-9439-452586a0880e3
637565dimethicone 10 MG/ML / zinc oxide 120 MG/ML Topical CreamSCD256dfcfc-a91c-49b0-9439-452586a0880e3
1053158Baza Protect (dimethicone 1 % / zinc oxide 12 % ) Topical CreamSY256dfcfc-a91c-49b0-9439-452586a0880e3
637565dimethicone 1 % / zinc oxide 12 % Topical CreamSY256dfcfc-a91c-49b0-9439-452586a0880e3
637565dimethicone 10 MG/ML / ZNO 120 MG/ML Topical CreamSY256dfcfc-a91c-49b0-9439-452586a0880e3
1053158dimethicone 10 MG/ML / ZNO 120 MG/ML Topical Cream [Baza-Protect]SY256dfcfc-a91c-49b0-9439-452586a0880e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11701-082-031170100820357 g in 1 TUBE (11701-082-03) 57 g2020-04-060000-00-00NoNoCurrent
11701-082-22117010082224 g in 1 PACKET (11701-082-22) 4 g2020-04-060000-00-00NoNoCurrent
11701-082-2411701008224142 g in 1 TUBE (11701-082-24) 142 g2020-04-060000-00-00NoNoCurrent