Cold Sore Treatment
- Product NDC
- 81522-922
- 11-digit product format
- 815220922
- Labeler code
- 81522
- Product ID
- 81522-922_7f6cfb0e-6357-4328-8fb3-25e99a0f9e85
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docosanol
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- FSA Store Inc. (Caring Mills)
- Application
- ANDA208754
- Marketing category
- ANDA
- Marketing start
- 2021-10-08
- Substance
- DOCOSANOL
- Active strength
- 100 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cold Sore Treatment
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOCOSANOL | 100 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9G1OE216XY |
| Rxcui | 797534 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81522-922-07 | Cold Sore Treatment | 2 g in 1 TUBE | CREAM | 2 | | 2 |
| 81522-922-07 | Cold Sore Treatment | 1 in 1 PACKAGE | CREAM | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81522-922 | COLD SORE TREATMENT (DOCOSANOL) CREAM [FSA STORE INC. (CARING MILLS)] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221202_a46e4d60-e84b-44a9-9d54-4861dbe91c59.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 |
|---|
| 81522-922-07 | 81522092207 | 1 TUBE in 1 PACKAGE (81522-922-07) / 2 g in 1 TUBE | 1 tube | 2021-10-08 | 0000-00-00 | No | No | Current |