Home NDC 69842-880 Docosanol
Product NDC 69842-880
11-digit product format 698420880
Labeler code 69842
Product ID 69842-880_dca4e3fe-7fe6-ccf2-9c99-9a57772bbe81
Type HUMAN OTC DRUG
Nonproprietary name Docosanol
Dosage form CREAM
Route TOPICAL
Labeler CVS Health Corp
Application ANDA214613
Marketing category ANDA
Marketing start 2021-07-02
Marketing end 0000-00-00
Substance DOCOSANOL
Active strength 100 mg/g
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 69842-880 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69842-880 69842-880-02 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214613-001 DOCOSANOL DOCOSANOL 10% CREAM / TOPICAL 2025-10-03
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A214613-001 DOCOSANOL 10% CREAM / TOPICAL 2025-10-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214613-001 DOCOSANOL 10% CREAM / TOPICAL 2025-10-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214613-001 DOCOSANOL 10% CREAM / TOPICAL 2025-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214613-001 DOCOSANOL 10% CREAM / TOPICAL 2025-10-03 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214613-001 DOCOSANOL 10% CREAM / TOPICAL 2025-10-03 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69842-880-02 Docosanol 2 g in 1 TUBE CREAM 2 3
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69842-880-02 69842088002 2 g in 1 TUBE (69842-880-02) 2 g 2021-07-02 0000-00-00 No No Current