XtraCare 2 in 1 Hair Cleanse and Condition

Product NDC
57337-064
11-digit product format
573370064
Labeler code
57337
Product ID
57337-064_9271a4fb-3648-2af5-e053-2a95a90a7dcf
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Rejoice International Inc.
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-08-27
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57337-064-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage57337-064-010efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ5XTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ5XTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0XTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RXTRACARE 2 IN 1 HAIR CLEANSE AND CONDITION COCONUT WATER (PYRITHIONE ZINC) SHAMPOO [REJOICE INTERNATIONAL INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57337-064-0157337006401400 g in 1 BOTTLE (57337-064-01) 400 g2014-08-270000-00-00NoNoCurrent