FDA.reportPublic FDA data

PanOxyl

Product NDC
0316-0227
11-digit product format
003160227
Labeler code
0316
Product ID
0316-0227_48343359-a966-5327-e063-6294a90a54e5
Type
HUMAN OTC DRUG
Nonproprietary name
benzoyl peroxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Crown Laboratories
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-03-25
Substance
BENZOYL PEROXIDE
Active strength
58.7 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE58.7 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-0227-062023-02-13C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0227-062023-02-13C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0227-062023-02-13C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0227-062023-01-30C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0227-062023-01-30C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0227-062023-01-30C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0227-06PanOxyl170 g in 1 TUBECREAM17026
0316-0227-06PanOxyl1 in 1 CARTONCREAM126
0316-0227-10PanOxyl1 in 1 CARTONCREAM126
0316-0227-10PanOxyl85 g in 1 TUBECREAM8526

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0227-06GM - Gram0316-0227a24cf241-a250-4e93-b697-1ac6387089ad12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0227PANOXYL (BENZOYL PEROXIDE) CREAM [CROWN LABORATORIES]23Current NDC, Legacy NDC, 4 package rows20240717_7b301b94-3cc8-b05b-e053-2991aa0aa561.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0227-06003160227061 TUBE in 1 CARTON (0316-0227-06) / 170 g in 1 TUBE1 tube2018-12-010000-00-00NoNoCurrent
0316-0227-10003160227101 in 1 CARTONHistorical