FDA.reportPublic FDA data

DOCOSANOL

Product NDC
58602-019
11-digit product format
586020019
Labeler code
58602
Product ID
58602-019_a0ddfc5f-c31c-4615-9545-11777b318454
Type
HUMAN OTC DRUG
Nonproprietary name
DOCOSANOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Aurohealth LLC
Application
ANDA217090
Marketing category
ANDA
Marketing start
2024-03-01
Substance
DOCOSANOL
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-02-19 14:30 UTC2026-02A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-018072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-016a51e52b5d6a…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217090-001DOCOSANOL10%CREAM / TOPICAL2024-03-01a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
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
9f361f24-a0a1-4e43-a158-8c830c9adca7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-019-08DOCOSANOL2 g in 1 TUBECREAM22
58602-019-08DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-09DOCOSANOL2 g in 1 TUBECREAM22
58602-019-09DOCOSANOL2 in 1 PACKAGECREAM22
58602-019-11DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-11DOCOSANOL3 g in 1 TUBECREAM32
58602-019-12DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-12DOCOSANOL3 g in 1 TUBECREAM32
58602-019-13DOCOSANOL3 g in 1 TUBECREAM32
58602-019-13DOCOSANOL2 in 1 PACKAGECREAM22
58602-019-15DOCOSANOL2 g in 1 BOTTLE, PUMPCREAM22
58602-019-15DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-16DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-16DOCOSANOL2 g in 1 BOTTLE, PUMPCREAM22
58602-019-17DOCOSANOL2 g in 1 BOTTLE, PUMPCREAM22
58602-019-17DOCOSANOL2 in 1 PACKAGECREAM22
58602-019-24DOCOSANOL1 in 1 PACKAGECREAM12
58602-019-24DOCOSANOL2 g in 1 TUBECREAM22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-019DOCOSANOL CREAM [AUROHEALTH LLC]2Current NDC, 18 package rows20240823_9f361f24-a0a1-4e43-a158-8c830c9adca7.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 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
ndc (product): 58602-019
AMAZON BASICS DOCOSANOLDOCOSANOLAmazon.com Services LLC3c28a462-c6d6-70ba-e063-6394a90ae8f32026-03-18WarningsExact identifier
application applno (ANDA): 217090
application number: ANDA217090
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797534docosanol 10 % Topical CreamPSN9f361f24-a0a1-4e43-a158-8c830c9adca72
797534docosanol 100 MG/ML Topical CreamSCD9f361f24-a0a1-4e43-a158-8c830c9adca72
797534docosanol 10 % Topical CreamSY9f361f24-a0a1-4e43-a158-8c830c9adca72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-019-08586020019081 TUBE in 1 PACKAGE (58602-019-08) / 2 g in 1 TUBE1 tube2024-03-01NoNoCurrent
58602-019-09586020019092 TUBE in 1 PACKAGE (58602-019-09) / 2 g in 1 TUBE2 tube2024-03-01NoNoCurrent
58602-019-11586020019111 TUBE in 1 PACKAGE (58602-019-11) / 3 g in 1 TUBE1 tube2024-03-01NoNoCurrent
58602-019-12586020019121 TUBE in 1 PACKAGE (58602-019-12) / 3 g in 1 TUBE1 tube2024-03-01NoNoCurrent
58602-019-13586020019132 TUBE in 1 PACKAGE (58602-019-13) / 3 g in 1 TUBE2 tube2024-03-01NoNoCurrent
58602-019-15586020019151 BOTTLE, PUMP in 1 PACKAGE (58602-019-15) / 2 g in 1 BOTTLE, PUMP2024-03-01NoNoCurrent
58602-019-16586020019161 BOTTLE, PUMP in 1 PACKAGE (58602-019-16) / 2 g in 1 BOTTLE, PUMP2024-03-01NoNoCurrent
58602-019-17586020019172 BOTTLE, PUMP in 1 PACKAGE (58602-019-17) / 2 g in 1 BOTTLE, PUMP2024-03-01NoNoCurrent
58602-019-24586020019241 TUBE in 1 PACKAGE (58602-019-24) / 2 g in 1 TUBE1 tube2024-03-01NoNoCurrent