FDA.reportPublic FDA data

Head and Shoulders

Product NDC
37000-094
11-digit product format
370000094
Labeler code
37000
Product ID
37000-094_4b1fe960-b470-f936-e063-6294a90a640e
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

Additional Listing Data#

Finished product
Yes
Brand name base
Head and Shoulders
Brand name suffix
Smooth and Silky
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRITHIONE ZINC1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR953O2RHZ5
Rxcui209884, 1043244

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-094-10Head and ShouldersSmooth and Silky10 mL in 1 POUCHLOTION/SHAMPOO1013
37000-094-37Head and ShouldersSmooth and Silky370 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO37013
37000-094-38Head and ShouldersSmooth and Silky380 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO38013
37000-094-40Head and ShouldersSmooth and Silky400 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO40013
37000-094-50Head and ShouldersSmooth and Silky50 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO5013
37000-094-61Head and ShouldersSmooth and Silky613 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO61313
37000-094-65Head and ShouldersSmooth and Silky650 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO65013
37000-094-70Head and ShouldersSmooth and Silky700 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO70013
37000-094-90Head and ShouldersSmooth and Silky90 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO9013
37000-094-10Head and Shoulders Dual SachetsSmooth and Silky10 mL in 1 POUCHLOTION/SHAMPOO10 mL1 g in 100mL2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ5HEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
Pyrithione ZincACTIVE MOIETYR953O2RHZ5HEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
Coco MonoethanolamideINACTIVE INGREDIENTC80684146DHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
glycol distearateINACTIVE INGREDIENT13W7MDN21WHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
magnesium carbonate hydroxideINACTIVE INGREDIENTYQO029V1L4HEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
magnesium sulfateINACTIVE INGREDIENTDE08037SABHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
methylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPNHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
methylisothiazolinoneINACTIVE INGREDIENT229D0E1QFAHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
sodium laureth-3 sulfateINACTIVE INGREDIENTBPV390UAP0HEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
sodium xylenesulfonateINACTIVE INGREDIENTG4LZF950URHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
WaterINACTIVE INGREDIENT059QF0KO0RHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2
zinc carbonateINACTIVE INGREDIENTEQR32Y7H0MHEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [PROCTER & GAMBLE MANUFACTURING CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-094HEAD AND SHOULDERS SMOOTH AND SILKY (PYRITHIONE ZINC) LOTION/SHAMPOO [THE PROCTER & GAMBLE MANUFACTURING COMPANY]11Current NDC, Legacy NDC, 9 package rows20241027_dbff64c1-f1f7-4f46-8a83-041e10312472.zip
37000-094HEAD AND SHOULDERS DUAL PACK SMOOTH AND SILKY (PYRITHIONE ZINC) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]4Current NDC, Legacy NDC20250524_a9500735-c938-0ad5-e053-2995a90afa50.zip
37000-094HEAD AND SHOULDERS DUAL SACHETS SMOOTH AND SILKY (PYRITHIONE ZINC) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2Current NDC, Legacy NDC20200110_7a2c32f7-182b-8959-e053-2991aa0a3a12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043244head & shoulders 1 % Medicated ShampooPSNdbff64c1-f1f7-4f46-8a83-041e1031247213
209884zinc pyrithione 1 % Medicated ShampooPSNdbff64c1-f1f7-4f46-8a83-041e1031247213
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBDdbff64c1-f1f7-4f46-8a83-041e1031247213
209884zinc pyrithione 10 MG/ML Medicated ShampooSCDdbff64c1-f1f7-4f46-8a83-041e1031247213
1043244Head & Shoulders 1 % Medicated ShampooSYdbff64c1-f1f7-4f46-8a83-041e1031247213
1043244Head & Shoulders 10 MG/ML Medicated ShampooSYdbff64c1-f1f7-4f46-8a83-041e1031247213
209884zinc pyrithione 1 % Medicated ConditionerSYdbff64c1-f1f7-4f46-8a83-041e1031247213
209884zinc pyrithione 1 % Medicated ShampooSYdbff64c1-f1f7-4f46-8a83-041e1031247213
1441654{1 (10 ML) (zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]) / 1 (10 ML) (zinc pyrithione 5 MG/ML Medicated Shampoo [Head & Shoulders]) } Pack [Head & Shoulders Dual Sachets]BPCK7a2c32f7-182b-8959-e053-2991aa0a3a122
1441653{1 (10 ML) (zinc pyrithione 10 MG/ML Medicated Shampoo) / 1 (10 ML) (zinc pyrithione 5 MG/ML Medicated Shampoo) } PackGPCK7a2c32f7-182b-8959-e053-2991aa0a3a122
1044465head & shoulders 0.5 % Medicated ShampooPSN19ad72ea-9a4b-0a35-e063-6394a90a91312
1044465head & shoulders 0.5 % Medicated ShampooPSN7a2c32f7-182b-8959-e053-2991aa0a3a122
1043244head & shoulders 1 % Medicated ShampooPSN7a2c32f7-182b-8959-e053-2991aa0a3a122
1043244head & shoulders 1 % Medicated ShampooPSN19ad72ea-9a4b-0a35-e063-6394a90a91312
1441654Head & Shoulders Dual Sachets PackPSN7a2c32f7-182b-8959-e053-2991aa0a3a122
1043014zinc pyrithione 0.5 % Medicated ConditionerPSN7a2c32f7-182b-8959-e053-2991aa0a3a122
1043014zinc pyrithione 0.5 % Medicated ConditionerPSN19ad72ea-9a4b-0a35-e063-6394a90a91312
209884zinc pyrithione 1 % Medicated ShampooPSN7a2c32f7-182b-8959-e053-2991aa0a3a122
209884zinc pyrithione 1 % Medicated ShampooPSN19ad72ea-9a4b-0a35-e063-6394a90a91312
1441653zinc pyrithione 1 % Medicated Shampoo (10 ML) / zinc pyrithione 0.5 % Medicated Conditioner (10 ML) PackPSN7a2c32f7-182b-8959-e053-2991aa0a3a122
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD7a2c32f7-182b-8959-e053-2991aa0a3a122
1043244zinc pyrithione 10 MG/ML Medicated Shampoo [Head & Shoulders]SBD19ad72ea-9a4b-0a35-e063-6394a90a91312
1044465zinc pyrithione 5 MG/ML Medicated Shampoo [Head & Shoulders]SBD7a2c32f7-182b-8959-e053-2991aa0a3a122
1044465zinc pyrithione 5 MG/ML Medicated Shampoo [Head & Shoulders]SBD19ad72ea-9a4b-0a35-e063-6394a90a91312
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD19ad72ea-9a4b-0a35-e063-6394a90a91312
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD7a2c32f7-182b-8959-e053-2991aa0a3a122
1043014zinc pyrithione 5 MG/ML Medicated ShampooSCD7a2c32f7-182b-8959-e053-2991aa0a3a122
1043014zinc pyrithione 5 MG/ML Medicated ShampooSCD19ad72ea-9a4b-0a35-e063-6394a90a91312
1044465Head & Shoulders 0.5 % ConditionerSY7a2c32f7-182b-8959-e053-2991aa0a3a122
1044465Head & Shoulders 0.5 % ConditionerSY19ad72ea-9a4b-0a35-e063-6394a90a91312
1043244Head & Shoulders 1 % Medicated ShampooSY7a2c32f7-182b-8959-e053-2991aa0a3a122
1043244Head & Shoulders 1 % Medicated ShampooSY19ad72ea-9a4b-0a35-e063-6394a90a91312
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY7a2c32f7-182b-8959-e053-2991aa0a3a122
1043244Head & Shoulders 10 MG/ML Medicated ShampooSY19ad72ea-9a4b-0a35-e063-6394a90a91312
1044465Head & Shoulders 5 MG/ML Medicated ShampooSY7a2c32f7-182b-8959-e053-2991aa0a3a122
1044465Head & Shoulders 5 MG/ML Medicated ShampooSY19ad72ea-9a4b-0a35-e063-6394a90a91312
1441654Head & Shoulders Dual Sachets PackSY7a2c32f7-182b-8959-e053-2991aa0a3a122
1441654Head & Shoulders Dual Sachets Pack (1 (0.34 FL OZ) (zinc pyrithione 1 % Medicated Shampoo [Head & Shoulders]) / 1 (0.34 FL OZ) (zinc pyrithione 0.5 % Medicated Conditioner [Head & Shoulders]))SY7a2c32f7-182b-8959-e053-2991aa0a3a122
1043014zinc pyrithione 0.5 % Medicated ShampooSY7a2c32f7-182b-8959-e053-2991aa0a3a122
1043014zinc pyrithione 0.5 % Medicated ShampooSY19ad72ea-9a4b-0a35-e063-6394a90a91312
209884zinc pyrithione 1 % Medicated ConditionerSY7a2c32f7-182b-8959-e053-2991aa0a3a122
209884zinc pyrithione 1 % Medicated ConditionerSY19ad72ea-9a4b-0a35-e063-6394a90a91312
209884zinc pyrithione 1 % Medicated ShampooSY7a2c32f7-182b-8959-e053-2991aa0a3a122
209884zinc pyrithione 1 % Medicated ShampooSY19ad72ea-9a4b-0a35-e063-6394a90a91312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-094-103700000941010 mL in 1 POUCH (37000-094-10) 10 ml2013-09-010000-00-00NoNoCurrent
37000-094-3737000009437370 mL in 1 BOTTLE, PLASTIC (37000-094-37) 370 ml2022-11-15NoNoCurrent
37000-094-3837000009438380 mL in 1 BOTTLE, PLASTIC (37000-094-38) 380 ml2017-10-110000-00-00NoNoCurrent
37000-094-4037000009440400 mL in 1 BOTTLE, PLASTIC400 mlHistorical
37000-094-503700000945050 mL in 1 BOTTLE, PLASTIC (37000-094-50) 50 ml2020-02-150000-00-00NoNoCurrent
37000-094-6137000009461613 mL in 1 BOTTLE, PLASTIC (37000-094-61) 613 ml2022-11-15NoNoCurrent
37000-094-6537000009465650 mL in 1 BOTTLE, PLASTIC (37000-094-65) 650 ml2017-10-110000-00-00NoNoCurrent
37000-094-7037000009470700 mL in 1 BOTTLE, PLASTIC700 mlHistorical
37000-094-903700000949090 mL in 1 BOTTLE, PLASTIC (37000-094-90) 90 ml2017-10-110000-00-00NoNoCurrent