FDA.reportPublic FDA data

PERIGIENE

Product NDC
61924-198
Requested package NDC
61924-198-08
11-digit product format
619240198
Labeler code
61924
Product ID
61924-198_9c5970fb-9b9a-6e87-e053-2a95a90a6889
Type
HUMAN OTC DRUG
Nonproprietary name
ANTIMICROBIAL DRUG PRODUCT
Dosage form
SOAP
Route
TOPICAL
Labeler
Dermarite Industries LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-12-12
Marketing end
0000-00-00
Substance
CHLOROXYLENOL
Active strength
0 g/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61924-19861924-198-08IInactivated by FDA2026-10-05

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61924-19861924-198-08IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61924-19861924-198-08IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61924-19861924-198-08IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61924-198-012026-01-29DRUG LISTING: PERIGIENE
61924-198-082026-01-29DRUG LISTING: PERIGIENE
61924-198-012023-12-06DRUG LISTING: PERIGIENE
61924-198-082023-12-06DRUG LISTING: PERIGIENE
61924-198-012022-01-28DRUG LISTING: PERIGIENE
61924-198-082022-01-28DRUG LISTING: PERIGIENE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-198-01PERIGIENE3800 mL in 1 JUGSOAP38007
61924-198-08PERIGIENE222 mL in 1 BOTTLE, SPRAYSOAP2227

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61924-198-01ML - Milliliter61924-1981752e76f-b38a-4960-904d-12239b8b14ef12015-10-02
61924-198-08ML - Milliliter61924-1981806fcfc-1995-4f0c-900c-5f900106c17612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ChloroxylenolACTIVE INGREDIENT0F32U78V2QPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
CHLOROXYLENOLACTIVE MOIETY0F32U78V2QPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KXPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
DMDM HydantoinINACTIVE INGREDIENTBYR0546TOWPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
LEMON OILINACTIVE INGREDIENTI9GRO824LLPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
MethylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPNPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
MethylisothiazolinoneINACTIVE INGREDIENT229D0E1QFAPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3PERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
SODIUM ISOSTEAROYL LACTYLATEINACTIVE INGREDIENT8730J0D3EVPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
Sodium Laureth SulfateINACTIVE INGREDIENTBPV390UAP0PERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RPERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-198PERIGIENE (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]7Legacy NDC, 2 package rows20241208_4f6e8610-f474-450e-a385-eaea58f649c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
436367chloroxylenol 0.5 % Medicated Liquid SoapPSN4f6e8610-f474-450e-a385-eaea58f649c87
1549631Perigiene 0.5 % Medicated Liquid SoapPSN4f6e8610-f474-450e-a385-eaea58f649c87
1549631chloroxylenol 5 MG/ML Medicated Liquid Soap [Perigiene]SBD4f6e8610-f474-450e-a385-eaea58f649c87
436367chloroxylenol 5 MG/ML Medicated Liquid SoapSCD4f6e8610-f474-450e-a385-eaea58f649c87
436367chloroxylenol 0.5 % Medicated Liquid SoapSY4f6e8610-f474-450e-a385-eaea58f649c87
1549631Perigiene 5 MG/ML Medicated Liquid SoapSY4f6e8610-f474-450e-a385-eaea58f649c87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61924-198-0861924019808222 mL in 1 BOTTLE, SPRAY (61924-198-08) 222 ml2011-12-120000-00-00NoNoCurrent