Home NDC 30142-981-07 Cold Sore Fever Blister Treatment
Product NDC 30142-981
Requested package NDC 30142-981-07
11-digit product format 301420981
Labeler code 30142
Product ID 30142-981_34741e80-d661-4c46-9d71-294c3090c813
Type HUMAN OTC DRUG
Nonproprietary name Docosanol
Dosage form CREAM
Route TOPICAL
Labeler The Kroger Co.
Application ANDA208754
Marketing category ANDA
Marketing start 2021-06-30
Marketing end 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208754-001 DOCOSANOL DOCOSANOL 10% CREAM / TOPICAL 2018-11-19
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 2026-08-01 22:54:32 2026-06 A208754-001 DOCOSANOL 10% CREAM / TOPICAL 2018-11-19 a50c72e98297…
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 2 · 32 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Cold Sore Fever Blister Treatment Active Ingredients# Ingredient, Strength table Ingredient Strength DOCOSANOL 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9G1OE216XY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 797534 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 30142-981-07 Cold Sore Fever Blister Treatment 2 g in 1 TUBE CREAM 2 4 30142-981-07 Cold Sore Fever Blister Treatment 1 in 1 PACKAGE CREAM 1 4 30142-981-14 Cold Sore Fever Blister Treatment 2 g in 1 TUBE CREAM 2 4 30142-981-14 Cold Sore Fever Blister Treatment 2 in 1 PACKAGE CREAM 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 30142-981 COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [THE KROGER CO.] 4 Current NDC, Legacy NDC, 4 package rows 20210921_42b46e02-4d1f-411e-be9e-227f62ba5a86.zip
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 30142-981-07 30142098107 1 TUBE in 1 PACKAGE (30142-981-07) / 2 g in 1 TUBE 1 tube 2021-06-30 0000-00-00 No No Current