FDA.reportPublic FDA data

AMAZON BASICS DOCOSANOL

Product NDC
72288-006
11-digit product format
722880006
Labeler code
72288
Product ID
72288-006_479ae2d4-63cb-4e54-b0fc-b0754b7929c1
Type
HUMAN OTC DRUG
Nonproprietary name
DOCOSANOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Amazon.com Services LLC
Application
ANDA217090
Marketing category
ANDA
Marketing start
2026-03-17
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217090-001DOCOSANOLDOCOSANOL10%CREAM / TOPICAL2024-03-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCOSANOLDOCOSANOLAurohealth LLC9f361f24-a0a1-4e43-a158-8c830c9adca72026-06-10WarningsExact identifier
application applno (ANDA): 217090
application number: ANDA217090
AMAZON BASICS DOCOSANOLDOCOSANOLAmazon.com Services LLC3c28a462-c6d6-70ba-e063-6394a90ae8f32026-03-18WarningsExact identifier
application applno (ANDA): 217090
application number: ANDA217090
ndc (product): 72288-006
DOCOSANOLDOCOSANOLKROGER COMPANY16ae0976-2940-27ae-e063-6394a90a62e82025-12-11WarningsExact identifier
application applno (ANDA): 217090
application number: ANDA217090
Cold Sore Treatment DocosanolDOCOSANOLBlistex Inc.bcdd51a9-210c-4d92-b67e-e3ac16c998122025-04-11WarningsExact identifier
application applno (ANDA): 217090
application number: ANDA217090
DOCOSANOLDOCOSANOLAmerisource Bergend6559957-0082-42b1-a43d-7c92cbd8b1a82024-10-01WarningsExact identifier
application applno (ANDA): 217090
application number: ANDA217090
Julie Cold Sore TreatmentDOCOSANOLJulie Products Inc113372a4-58de-f829-e063-6294a90a4eb12024-07-19WarningsExact identifier
application applno (ANDA): 217090
application number: ANDA217090

Additional Listing Data#

Finished product
Yes
Brand name base
AMAZON BASICS DOCOSANOL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCOSANOL100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9G1OE216XYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
797534Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c28a462-c6d6-70ba-e063-6394a90ae8f3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-006-01AMAZON BASICS DOCOSANOL2 g in 1 TUBECREAM23
72288-006-01AMAZON BASICS DOCOSANOL1 in 1 PACKAGECREAM13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN3c28a462-c6d6-70ba-e063-6394a90ae8f33
797534docosanol 100 MG/ML Topical CreamSCD3c28a462-c6d6-70ba-e063-6394a90ae8f33
797534docosanol 10 % Topical CreamSY3c28a462-c6d6-70ba-e063-6394a90ae8f33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-006-01722880006011 TUBE in 1 PACKAGE (72288-006-01) / 2 g in 1 TUBE1 tube2026-03-17NoNoCurrent