FDA.reportPublic FDA data

Oribe Serene Scalp Anti Dandruff

Product NDC
71438-010
11-digit product format
714380010
Labeler code
71438
Product ID
71438-010_2aa42f1e-b0be-85fa-e063-6394a90adf2e
Type
HUMAN OTC DRUG
Nonproprietary name
Oribe Serene Scalp Anti Dandruff
Dosage form
LOTION
Route
TOPICAL
Labeler
Oribe Hair Care LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-04
Substance
SALICYLIC ACID
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage71438-010-12fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage71438-010-1286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage71438-010-12bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage71438-010-128dfbde2a14a4…c9ff85d89658…

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
Oribe Serene Scalp Anti Dandruff
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100g

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
205104Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e5702ac7-e680-ab4b-e053-2995a90ad442Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-09-21DRUG FACTS
2021-07-23DRUG FACTS
2020-03-11DRUG FACTS
2020-01-31DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71438-010-12Oribe Serene Scalp Anti Dandruff1 in 1 CARTONLOTION19
71438-010-12Oribe Serene Scalp Anti Dandruff120 g in 1 TUBELOTION1209
71438-010-07Oribe Serene Scalp Anti Dandruff7 g in 1 PACKETLOTION74
71438-010-07Oribe Serene Scalp Anti Dandruff1 in 1 CARTONLOTION14
71438-010-20Oribe Serene Scalp Anti Dandruff1 in 1 CARTONLOTION14
71438-010-20Oribe Serene Scalp Anti Dandruff1000 g in 1 BOTTLE, PUMPLOTION10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71438-010ORIBE SERENE SCALP ANTI DANDRUFF LOTION [ORIBE HAIR CARE LLC]7Current NDC, Legacy NDC, 2 package rows20250102_34c4abb5-6f96-4866-a37f-4f9be6c43f2b.zip
71438-010ORIBE SERENE SCALP ANTI DANDRUFF LOTION [ORIBE HAIR CARE LLC]4Current NDC, Legacy NDC, 2 package rows20250102_abaf1c64-1c4d-481a-9872-b64fcf82cc63.zip
71438-010ORIBE SERENE SCALP ANTI DANDRUFF LOTION [ORIBE HAIR CARE LLC]4Current NDC, Legacy NDC, 2 package rows20250102_e5702ac7-e680-ab4b-e053-2995a90ad442.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 25 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer T Plus Gel Coal Tar Anti-DandruffCOAL TARMeijer Distribution, Incc4b0d6e5-0756-45e8-bdfc-a8ba728b246b2024-11-05WarningsExact identifier
application number: M032
Walgreens Dandruff Conditioner 2 in 1 Itchy Scalp Anti-dandruffPYRITHIONE ZINCWalgreen Company52594e2b-dd1b-4618-b1ab-9f65ae26a3582024-11-04WarningsExact identifier
application number: M032
Walgreens Dandruff Plus Conditioner 2 in 1 Anti-dandruffPYRITHIONE ZINCWalgreen Company12ccb5aa-4e0d-467b-a03c-dddd6da0a9c92024-11-04WarningsExact identifier
application number: M032
Walgreens Dandruff Plus Conditioner 2 in 1 Dry Scalp Anti-dandruffPYRITHIONE ZINCWalgreen Company0fed00b3-cac6-4add-b979-a3fe112bcff32024-11-04WarningsExact identifier
application number: M032
Walgreens Dandruff Itchy Dry Scalp Defense Anti-dandruffPYRITHIONE ZINCWalgreen Company06b37d44-9ebf-44ed-8e8b-492905d85bdc2024-11-01WarningsExact identifier
application number: M032
Walgreens Dandruff Conditioner 2 in 1 Itchy Scalp Anti-dandruffPYRITHIONE ZINCWalgreen Company5b679112-8790-416f-9bb4-8e64d3e279bc2024-11-01WarningsExact identifier
application number: M032
Walgreens Dandruff Itchy Dry Scalp Defense Plus Vitamins and Botanicals Anti-dandruffSALICYLIC ACIDWalgreen Company2776d45c-6597-4c13-81e6-29d9248e9e562024-11-01WarningsExact identifier
application number: M032
Walgreens Dandruff and Conditioner Cleansing and Conditioning Anti-dandruffSELENIUM SULFIDEWalgreen Companydbcaeae8-4680-41d8-84e2-896183d2121d2024-11-01WarningsExact identifier
application number: M032
Walgreens Dandruff Maximum Strength Anti-dandruffSELENIUM SULFIDEWalgreen Company0187b034-44d7-4b84-af04-d018bc9750f32024-11-01WarningsExact identifier
application number: M032
Dermarest Psoriasis MedicatedSALICYLIC ACIDInsight Pharmaceuticals LLCc6a64946-bafd-449f-90cc-e2f6201285f32024-10-25WarningsExact identifier
application number: M032
DermaSolve MedicatedSALICYLIC ACIDFortitude Health, LLC253e2687-6e8b-48ec-e063-6394a90aa20b2024-10-24WarningsExact identifier
application number: M032
FAMILY Wellness FRESH and CLEAN DANDRUFF PLUS CONDITIONER 2 IN 1 Anti-DandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INC4a9a803a-44ac-4e29-9c47-0073b728ff192024-10-22WarningsExact identifier
application number: M032
DermaSolve MedicatedSALICYLIC ACIDFortitude Health, LLC24fea3b2-1f0a-e289-e063-6394a90a56412024-10-21WarningsExact identifier
application number: M032
FAMILY Wellness EVERYDAY CLEAN 2 IN 1 DANDRUFF PLUS CONDITIONER Anti-DandruffPYRITHIONE ZINCFAMILY DOLLAR SERVICES INC220955ec-592c-421f-9f4e-545ff3843ee02024-10-21WarningsExact identifier
application number: M032
FAMILY Wellness MAXIMUM STRENGTH DANDRUFF Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSELENIUM SULFIDEFAMILY DOLLAR SERVICES INC41a808e1-67a7-4b29-8ec4-d6c13cf622432024-10-21WarningsExact identifier
application number: M032
Family Wellness Therapeutic Tplus PLUS Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisCOAL TARFAMILY DOLLAR SERVICES INC46471dfa-2322-464f-8d00-bf49d8eb4e182024-10-21WarningsExact identifier
application number: M032
As I Am Dry and Itchy Scalp Care ConditionerPYRITHIONE ZINCSalon Commodities, Inc.71eb9451-df12-66e8-e053-2a95a90a2f692024-10-09WarningsExact identifier
application number: M032
As I Am Dry and Itchy Scalp Care TreatmentSALICYLIC ACIDSalon Commodities, Inc.71ec25c5-6da5-670a-e053-2a95a90a1b8c2024-10-09WarningsExact identifier
application number: M032
KeraCare Dry and Itchy Scalp Anti-DandruffPYRITHIONE ZINCAvlon Industries, Inc.6e7524d7-b280-485a-815e-8af078e8acda2024-10-09WarningsExact identifier
application number: M032
KeraCare Dry and Itchy Scalp Anti-DandruffPYRITHIONE ZINCAvlon Industries, Inc.5d501ba0-a6f9-4f0d-86d5-0e8d9302737f2024-10-09WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205104salicylic acid 2 % Medicated ShampooPSN34c4abb5-6f96-4866-a37f-4f9be6c43f2b9
205104salicylic acid 20 MG/ML Medicated ShampooSCD34c4abb5-6f96-4866-a37f-4f9be6c43f2b9
205104salicylic acid 2 % Medicated ConditionerSY34c4abb5-6f96-4866-a37f-4f9be6c43f2b9
205104salicylic acid 2 % Medicated ShampooSY34c4abb5-6f96-4866-a37f-4f9be6c43f2b9
205104salicylic acid 2 % Medicated ShampooPSNabaf1c64-1c4d-481a-9872-b64fcf82cc634
205104salicylic acid 2 % Medicated ShampooPSNe5702ac7-e680-ab4b-e053-2995a90ad4424
205104salicylic acid 20 MG/ML Medicated ShampooSCDabaf1c64-1c4d-481a-9872-b64fcf82cc634
205104salicylic acid 20 MG/ML Medicated ShampooSCDe5702ac7-e680-ab4b-e053-2995a90ad4424
205104salicylic acid 2 % Medicated ConditionerSYabaf1c64-1c4d-481a-9872-b64fcf82cc634
205104salicylic acid 2 % Medicated ConditionerSYe5702ac7-e680-ab4b-e053-2995a90ad4424
205104salicylic acid 2 % Medicated ShampooSYabaf1c64-1c4d-481a-9872-b64fcf82cc634
205104salicylic acid 2 % Medicated ShampooSYe5702ac7-e680-ab4b-e053-2995a90ad4424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71438-010-07714380010071 PACKET in 1 CARTON (71438-010-07) / 7 g in 1 PACKET1 packet2022-08-040000-00-00NoNoCurrent
71438-010-12714380010121 TUBE in 1 CARTON (71438-010-12) / 120 g in 1 TUBE1 tube2017-11-200000-00-00NoNoCurrent
71438-010-20714380010201 BOTTLE, PUMP in 1 CARTON (71438-010-20) / 1000 g in 1 BOTTLE, PUMP2022-10-050000-00-00NoNoCurrent