FDA.reportPublic FDA data

Elementz

Product NDC
51870-007
11-digit product format
518700007
Labeler code
51870
Product ID
51870-007_d36e9d0c-9383-5390-e053-2995a90a3620
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Keefe Group
Application
part358H
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-06-10
Marketing end
0000-00-00
Substance
PYRITHIONE ZINC
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51870-007IInactivated by FDA2026-10-15
excluded packagepackage51870-00751870-007-15IInactivated by FDA2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51870-007-152024-01-02C16284748780-1f386c649-a713-0266-e053-dadaa90a7c1aElementz Dandruff Shampoo
51870-007-152023-01-30C16284748780-1f386c649-a713-0266-e053-dadaa90a7c1aElementz Dandruff Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51870-007-15Elementz443 mL in 1 BOTTLE, PLASTICSHAMPOO4434

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51870-007ELEMENTZ (PYRITHIONE ZINC) SHAMPOO [KEEFE GROUP]4Legacy NDC, 1 package rows20240103_8ad4a94f-8164-05b9-e053-2a95a90ac5f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN8ad4a94f-8164-05b9-e053-2a95a90ac5f04
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD8ad4a94f-8164-05b9-e053-2a95a90ac5f04
209884zinc pyrithione 1 % Medicated ConditionerSY8ad4a94f-8164-05b9-e053-2a95a90ac5f04
209884zinc pyrithione 1 % Medicated ShampooSY8ad4a94f-8164-05b9-e053-2a95a90ac5f04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51870-007-1551870000715443 mL in 1 BOTTLE, PLASTIC (51870-007-15) 443 ml2019-06-100000-00-00NoNoCurrent