Head and Shoulders

Product NDC
37000-078
Requested package NDC
37000-078-83
11-digit product format
370000078
Labeler code
37000
Product ID
37000-078_4cda90a8-cfc7-00fd-e063-6294a90aa27d
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrithione Zinc
Dosage form
LOTION/SHAMPOO
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-01
Substance
PYRITHIONE ZINC
Active strength
1 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Head and Shoulders
Brand name suffix
Green Apple 2in1
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC1 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R953O2RHZ5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
209884Internal RxNorm lookup
1043244Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c036c9a6-6507-4037-b97b-1b015dd950c1Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-078-012022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-012022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-112022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-112022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-122022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-122022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-252022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-252022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-402022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-402022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-702022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-702022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-952022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-952022-04-11Head and Shoulders ® Green Apple 2in1
37000-078-012021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-012021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-112021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-112021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-122021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-122021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-252021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-252021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-402021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-402021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-702021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-702021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-952021-01-29Head and Shoulders ® Green Apple 2in1
37000-078-952021-01-29Head and Shoulders ® Green Apple 2in1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-078-01Head and ShouldersGreen Apple 2in11000 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO100013
37000-078-02Head and ShouldersGreen Apple 2in1950 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO95013
37000-078-02Head and ShouldersGreen Apple 2in12 in 1 CELLO PACKLOTION/SHAMPOO213
37000-078-11Head and ShouldersGreen Apple 2in11180 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO118013
37000-078-12Head and ShouldersGreen Apple 2in11280 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO128013
37000-078-25Head and ShouldersGreen Apple 2in1250 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO25013
37000-078-37Head and ShouldersGreen Apple 2in1370 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO37013
37000-078-40Head and ShouldersGreen Apple 2in1400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO40013
37000-078-61Head and ShouldersGreen Apple 2in1613 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO61313
37000-078-70Head and ShouldersGreen Apple 2in1700 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO70013
37000-078-83Head and ShouldersGreen Apple 2in1835 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO83513
37000-078-95Head and ShouldersGreen Apple 2in1950 mL in 1 BOTTLE, PUMPLOTION/SHAMPOO95013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ5HEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
Pyrithione ZincACTIVE MOIETYR953O2RHZ5HEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
cocamidopropyl betaineINACTIVE INGREDIENT5OCF3O11KXHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
FD&C yellow no. 5INACTIVE INGREDIENTI753WB2F1MHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
glycol distearateINACTIVE INGREDIENT13W7MDN21WHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
magnesium carbonate hydroxideINACTIVE INGREDIENTYQO029V1L4HEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
methylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPNHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFAHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
sodium laureth-3 sulfateINACTIVE INGREDIENTBPV390UAP0HEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
sodium xylenesulfonateINACTIVE INGREDIENTG4LZF950URHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
waterINACTIVE INGREDIENT059QF0KO0RHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3
zinc carbonateINACTIVE INGREDIENTEQR32Y7H0MHEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-078HEAD AND SHOULDERS GREEN APPLE 2IN1 (PYRITHIONE ZINC) LOTION/SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]12Current NDC, Legacy NDC, 12 package rows20241020_c036c9a6-6507-4037-b97b-1b015dd950c1.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 2 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
apgwgzminoxidil2%MINOXIDILGuangdong Jiaoyu Biotechnology Co., Ltd5957c990-e274-6278-e063-6394a90af2b72026-08-18WarningsExact identifier
application number: M032
EVERYDAY CLEAN DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC3983b688-28ae-462e-8686-6cf2f2c1cca42026-08-18WarningsExact identifier
application number: M032
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.378311aa-95f7-4c69-bc00-e688468262bd2026-08-18WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC496e178b-e29b-071e-e063-6394a90aa0182026-08-13WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis shampoo.SALICYLIC ACID 3%RoyceDerm LLC4995ce33-e231-8f86-e063-6394a90af4862026-08-13WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast ReliefPYRITHIONE ZINCRida LLCd1e4dee7-5962-4ec1-ab99-9d547077b2f22026-08-05WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief TreatmentSALICYLIC ACIDRida LLC6226ce12-432f-402e-bda7-a5ca96f0b8382026-08-05WarningsExact identifier
application number: M032
JOHNSON FOAMMINOXIDILJOHNSON BIOPHARMACEUTICAL INC.1d44a75c-c940-680c-e063-6394a90a58392026-08-02WarningsExact identifier
application number: M032
EVERYDAY CLEAN DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a03d4bb-72e6-cc9f-e063-6394a90ae19f2026-08-01WarningsExact identifier
application number: M032
TEA TREE Oil DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a0505a6-77ca-c56e-e063-6394a90aea6f2026-08-01WarningsExact identifier
application number: M032
ITCHY SCALP RELIEF DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a0521cd-2b9e-e02c-e063-6394a90a5f022026-08-01WarningsExact identifier
application number: M032
SMOOTH AND SOFT DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a054179-b0d7-3a0f-e063-6294a90a62092026-08-01WarningsExact identifier
application number: M032
FOLKI COSMETIC Psoriasis CreamSALICYLIC ACID 3% PSORIASIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.575786e0-21b8-ad9d-e063-6394a90ad0d42026-07-24WarningsExact identifier
application number: M032
RoyceDerm Psoriasis Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC57425b1a-4cf3-b133-e063-6394a90a84f52026-07-23WarningsExact identifier
application number: M032
RoyceDerm Psoriasis Scalp .Shampoo.SALICYLIC ACID 3%RoyceDerm LLC5743f813-57f7-f544-e063-6294a90ad3b82026-07-23WarningsExact identifier
application number: M032
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M032
Pureskin Seborrheic Dermatitis and Psoriasis CreamSEBORRHEIC DERMATITIS PSORIASIS CREAMBENLONG HALL LLC36086f7f-8536-417f-a302-37f78288489e2026-07-20WarningsExact identifier
application number: M032
5%MINOXIDIL TOPICAL FOAMMINOXIDILVeloce Trading Co., Limited56f87881-653f-17e6-e063-6294a90a67872026-07-19WarningsExact identifier
application number: M032
ProBliva Psoriasis Shampoo.SALICYLIC ACID 3%CAVTECH HOLDING LLC563e75f9-a1e2-2796-e063-6294a90aedb42026-07-10WarningsExact identifier
application number: M032
ProBliva Anti Dandruff Shampoo.SELENIUM SULFIDE 1%CAVTECH HOLDING LLC56022f6b-d7ba-1ccd-e063-6294a90a73102026-07-07WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043244head & shoulders 1 % Medicated ShampooPSNc036c9a6-6507-4037-b97b-1b015dd950c113
209884zinc pyrithione 1 % Medicated ShampooPSNc036c9a6-6507-4037-b97b-1b015dd950c113
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBDc036c9a6-6507-4037-b97b-1b015dd950c113
209884zinc pyrithione 10 MG/ML Medicated ShampooSCDc036c9a6-6507-4037-b97b-1b015dd950c113
1043244Head & Shoulders 1 % Medicated ShampooSYc036c9a6-6507-4037-b97b-1b015dd950c113
1043244Head & Shoulders 10 MG/ML Medicated ShampooSYc036c9a6-6507-4037-b97b-1b015dd950c113
209884zinc pyrithione 1 % Medicated ConditionerSYc036c9a6-6507-4037-b97b-1b015dd950c113
209884zinc pyrithione 1 % Medicated ShampooSYc036c9a6-6507-4037-b97b-1b015dd950c113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37000-078-8337000007883835 mL in 1 BOTTLE, PUMP (37000-078-83) 835 ml2022-12-01NoNoCurrent