FDA.reportPublic FDA data

ABREVA

Product NDC
0135-0200
11-digit product format
001350200
Labeler code
0135
Product ID
0135-0200_1b525ee7-41df-5a73-e063-6294a90a0b86
Type
HUMAN OTC DRUG
Nonproprietary name
docosanol
Dosage form
CREAM
Route
TOPICAL
Labeler
Haleon US Holdings LLC
Application
NDA020941
Marketing category
NDA
Marketing start
2010-03-19
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ABREVA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G1OE216XY
Rxcui797534, 855205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-0200-012020-10-06C16284748780-19d75b9d1-1b99-f424-e053-dadaa90a57ceDrug Facts
0135-0200-032020-10-06C16284748780-19d75b9d1-1b99-f424-e053-dadaa90a57ceDrug Facts
0135-0200-042020-10-06C16284748780-19d75b9d1-1b99-f424-e053-dadaa90a57ceDrug Facts
0135-0200-052020-10-06C16284748780-19d75b9d1-1b99-f424-e053-dadaa90a57ceDrug Facts
0135-0200-012020-01-31C16284748780-19d75b9d1-1b99-f424-e053-dadaa90a57ceDrug Facts
0135-0200-032020-01-31C16284748780-19d75b9d1-1b99-f424-e053-dadaa90a57ceDrug Facts
0135-0200-042020-01-31C16284748780-19d75b9d1-1b99-f424-e053-dadaa90a57ceDrug Facts
0135-0200-052020-01-31C16284748780-19d75b9d1-1b99-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0200-01ABREVA2 g in 1 TUBECREAM216
0135-0200-03ABREVA2 g in 1 BOTTLE, PUMPCREAM216
0135-0200-04ABREVA2 g in 1 TUBECREAM216
0135-0200-04ABREVA2 in 1 PACKAGECREAM216
0135-0200-05ABREVA2 g in 1 TUBECREAM216
0135-0200-05ABREVA2 in 1 PACKAGECREAM216
0135-0200-06ABREVA2 g in 1 BOTTLE, PUMPCREAM216
0135-0200-06ABREVA3 in 1 PACKAGECREAM316

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0200-01GM - Gram0135-02003ef7e703-fc30-449e-a5cd-21670dfd305d12012-07-24
0135-0200-03GM - Gram0135-0200c31659c2-e299-40ca-a41a-5ac16e27948112012-07-24
0135-0200-05GM - Gram0135-020070ef30a4-324f-46d2-8b07-d75741ffaa7512017-07-07
0135-0200-06GM - Gram0135-0200623cfb8d-fa47-471d-a8b5-b07e48c439ab12025-02-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCOSANOLACTIVE INGREDIENT9G1OE216XYABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
DOCOSANOLACTIVE MOIETY9G1OE216XYABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SUCROSE DISTEARATEINACTIVE INGREDIENT33X4X4B90SABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50MABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6
WATERINACTIVE INGREDIENT059QF0KO0RABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0200ABREVA (DOCOSANOL) CREAM [HALEON US HOLDINGS LLC]16Current NDC, Legacy NDC, 8 package rows20240621_c39b38a7-dcdd-4c32-8f35-b565c4d3cec6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855205Abreva 10 % Topical CreamPSNc39b38a7-dcdd-4c32-8f35-b565c4d3cec616
797534docosanol 10 % Topical CreamPSNc39b38a7-dcdd-4c32-8f35-b565c4d3cec616
855205docosanol 100 MG/ML Topical Cream [Abreva]SBDc39b38a7-dcdd-4c32-8f35-b565c4d3cec616
797534docosanol 100 MG/ML Topical CreamSCDc39b38a7-dcdd-4c32-8f35-b565c4d3cec616
855205Abreva 10 % Topical CreamSYc39b38a7-dcdd-4c32-8f35-b565c4d3cec616
797534docosanol 10 % Topical CreamSYc39b38a7-dcdd-4c32-8f35-b565c4d3cec616
855205Abreva 10 % Topical CreamPSN8b292cc5-c9ec-44ab-8c08-ba153a58d9fd5
797534docosanol 10 % Topical CreamPSN8b292cc5-c9ec-44ab-8c08-ba153a58d9fd5
855205docosanol 100 MG/ML Topical Cream [Abreva]SBD8b292cc5-c9ec-44ab-8c08-ba153a58d9fd5
797534docosanol 100 MG/ML Topical CreamSCD8b292cc5-c9ec-44ab-8c08-ba153a58d9fd5
855205Abreva 10 % Topical CreamSY8b292cc5-c9ec-44ab-8c08-ba153a58d9fd5
797534docosanol 10 % Topical CreamSY8b292cc5-c9ec-44ab-8c08-ba153a58d9fd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0200-01001350200012 g in 1 TUBE (0135-0200-01) 2 g2010-03-190000-00-00NoNoCurrent
0135-0200-03001350200032 g in 1 BOTTLE, PUMP (0135-0200-03) 2 g2010-03-190000-00-00NoNoCurrent
0135-0200-04001350200042 g in 1 TUBE2 gHistorical
0135-0200-05001350200052 TUBE in 1 PACKAGE (0135-0200-05) / 2 g in 1 TUBE2 tube2017-07-060000-00-00NoNoCurrent
0135-0200-06001350200063 BOTTLE, PUMP in 1 PACKAGE (0135-0200-06) / 2 g in 1 BOTTLE, PUMP2024-01-02NoNoCurrent