FDA.reportPublic FDA data

Denorex Extra Strength

Product NDC
62673-059
Requested package NDC
62673-059-10
11-digit product format
626730059
Labeler code
62673
Product ID
62673-059_4ed2043a-0f5e-a764-e063-6394a90aa3bd
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Neoteric Cosmetics, Inc.
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-17
Marketing end
2029-02-28
Substance
SALICYLIC ACID
Active strength
.03 g/mL
NDC exclude flag
No
Current FDA listing
Yes

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 · 7 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Denorex Extra Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID.03 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205023Internal RxNorm lookup
1303358Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
21d234ff-f379-4bcd-9ba0-90f27c6d3a69Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62673-059-102024-12-18C16284748780-1e4f33bdf-a537-d8a0-e053-dadaa90a6e4eDenorex Extra Strength with Conditioner
62673-059-102022-07-29C16284748780-1e4f33bdf-a537-d8a0-e053-dadaa90a6e4eDenorex Extra Strength with Conditioner

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62673-059-10Denorex Extra Strength296 mL in 1 BOTTLESHAMPOO2964

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62673-059DENOREX EXTRA STRENGTH (SALICYLIC ACID) SHAMPOO [NEOTERIC COSMETICS, INC.]3Current NDC, Legacy NDC, 1 package rows20250523_21d234ff-f379-4bcd-9ba0-90f27c6d3a69.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 19 of 32 · 630 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pert 2 in 1 Advanced plusSALICYLIC ACIDSodalis USA, LLC0eaed46c-ae6f-0d58-e063-6394a90ad2a32025-08-13WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Dandruff Medicated Cleansing BarPYRITHIONE ZINC 2%RoyceDerm LLC3b98a83d-9c3b-9522-e063-6294a90a70332025-08-05WarningsExact identifier
application number: M032
Earthmed FS Psoriasis reliefSALICYLIC ACIDEarthmed LLC3ba584bc-f40a-ce0a-e063-6394a90aebf72025-08-05WarningsExact identifier
application number: M032
Pert 2 in 1 Extra StrengthSALICYLIC ACIDSodalis USA, LLC25c8a46c-4400-709f-e063-6394a90a3f312025-07-30WarningsExact identifier
application number: M032
anti-fungalANTI-FUNGAL SHAMPOOGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd3b102d15-f2ce-5727-e063-6294a90a23a92025-07-29WarningsExact identifier
application number: M032
Earthmed Sport Anti itch and eczema reliefSALICYLIC ACIDEarthmed LLC3b14913b-3aab-9dd0-e063-6394a90a3b7f2025-07-29WarningsExact identifier
application number: M032
Soothing psoriasis and eczema reliefSALICYLIC ACIDCarolina Cannabis Creations L.L.C2bcad94d-1918-7f37-e063-6294a90a47442025-07-29WarningsExact identifier
application number: M032
DANDRX ANTI-DANDRUFFZINC PYRITHIONEdandRX LLC399fb507-2263-962f-e063-6394a90ae9a82025-07-10WarningsExact identifier
application number: M032
anti-dandruffANTI-DANDRUFF SHAMPOOGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd3979fb80-8091-c79e-e063-6394a90ae6182025-07-09WarningsExact identifier
application number: M032
CeraVe 2 in 1 Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc7f5ff142-15cb-44be-aa0e-ccd06de233002025-07-08WarningsExact identifier
application number: M032
5% Minoxidil and 5% Rosemary for Hair CareMINOXIDILTIKNOW LLC1bb386d2-70c6-c487-e063-6294a90a19da2025-07-07WarningsExact identifier
application number: M032
Red Scalpfixer Anti DandruffPYRINTHIONE ZINCOrange Lab, Inc386c83c3-8d23-b3b0-e063-6394a90a27ee2025-07-01WarningsExact identifier
application number: M032
Dermabon Multi Symptom Psoriasis ControlCOAL TARDermabon de Chihuahua, S.A. de C.V.d5b739ba-e332-41f6-9343-6ad5cc9813442025-07-01WarningsExact identifier
application number: M032
PHARMBANNER Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.383926b7-997b-af1e-e063-6394a90a506d2025-06-23WarningsExact identifier
application number: M032
Brickell Mens Products Relieving Anti-DandruffSALICYLIC ACIDBRICKELL BRANDS LLC7ba3b13b-cb78-4df8-8719-c88e556643b42025-06-16WarningsExact identifier
application number: M032
VENROCKPIROCTONE OLAMINE AND SALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.372feca7-f6f1-cd38-e063-6294a90a3bfe2025-06-12WarningsExact identifier
application number: M032
Neutrogena T/Sal TherapeuticSALICYLIC ACIDKenvue Brands LLC54707f0f-6025-4dc3-8be8-7a38bb1363b82025-06-05WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SAaae04d08-9d0c-43bd-89c2-741884de3bea2025-06-04WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDL'Oreal USA Products Incbcffd505-82bd-45ce-9ad0-64a9e63f62b52025-06-04WarningsExact identifier
application number: M032
UCHOIZE S2 Balance Anti-DandruffUCHOIZE S2 BALANCE ANTI-DANDRUFF SHAMPOODreamwise International Corp36a5efa8-0617-868d-e063-6394a90a17052025-06-03WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1303358Denorex Extra Strength 3 % Medicated Shampoo, Reformulated Aug 2012PSN21d234ff-f379-4bcd-9ba0-90f27c6d3a694
205023salicylic acid 3 % Medicated ShampooPSN21d234ff-f379-4bcd-9ba0-90f27c6d3a694
1303358salicylic acid 30 MG/ML Medicated Shampoo [Denorex Extra Strength Reformulated Aug 2012]SBD21d234ff-f379-4bcd-9ba0-90f27c6d3a694
205023salicylic acid 30 MG/ML Medicated ShampooSCD21d234ff-f379-4bcd-9ba0-90f27c6d3a694
1303358Denorex Extra Strength 3 % Medicated Shampoo, Reformulated Aug 2012SY21d234ff-f379-4bcd-9ba0-90f27c6d3a694
1303358Denorex Extra Strength Reformulated Aug 2012 30 MG/ML Medicated ShampooSY21d234ff-f379-4bcd-9ba0-90f27c6d3a694
205023salicylic acid 3 % Medicated ShampooSY21d234ff-f379-4bcd-9ba0-90f27c6d3a694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62673-059-1062673005910296 mL in 1 BOTTLE (62673-059-10) 296 ml2019-06-172029-02-28NoNoCurrent