Docosanol

Product NDC: 84725-001
11-digit product format: 847250001
Labeler code: 84725
Product ID: 84725-001_cbd03a44-aac9-4ae2-8275-d1967ca22043
Type: HUMAN OTC DRUG
Nonproprietary name: Docosanol
Dosage form: CREAM
Route: TOPICAL
Labeler: KLM Laboratories Private Limited
Application: ANDA220017
Marketing category: ANDA
Marketing start: 2026-09-08
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 44.

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
A220017-001	DOCOSANOL	DOCOSANOL	10%	CREAM / TOPICAL			2026-07-31

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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A220017-001	DOCOSANOL	10%	CREAM / TOPICAL	2026-07-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A220017-001	DOCOSANOL	10%	CREAM / TOPICAL	2026-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A220017-001	DOCOSANOL	10%	CREAM / TOPICAL	2026-07-31	`caaa826d4ba7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Docosanol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCOSANOL	100 mg/g

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9G1OE216XY	DOCOSANOL	661-19-8	DOCOSANOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84725-001-01	84725000101	1 TUBE in 1 PACKAGE (84725-001-01) / 2 g in 1 TUBE	1 tube	2026-09-08	No	No	Current
84725-001-02	84725000102	1 BOTTLE, PUMP in 1 PACKAGE (84725-001-02) / 2 g in 1 BOTTLE, PUMP		2026-09-08	No	No	Current
84725-001-09	84725000109	2 TUBE in 1 PACKAGE (84725-001-09) / 2 g in 1 TUBE	2 tube	2026-10-01	No	No	Current