acetic acid
- Product NDC
- 21695-222
- 11-digit product format
- 216950222
- Labeler code
- 21695
- Product ID
- 21695-222_a8c12387-4b2b-49c2-b9c5-112ffb133950
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetic acid
- Dosage form
- SOLUTION
- Route
- AURICULAR (OTIC)
- Labeler
- Rebel Distributors Corp
- Application
- NDA012179
- Marketing category
- NDA
- Marketing start
- 2010-01-22
- Marketing end
- 0000-00-00
- Substance
- ACETIC ACID
- Active strength
- 21 mg/mL
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-222-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4a2b-48b1-e053-8cdaa90a720a | Acetic Acid Otic Solution, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-222-15 | acetic acid | 15 mL in 1 BOTTLE | SOLUTION | 15 | 1 | |
| 21695-222-15 | acetic acid | 1 in 1 BOX | SOLUTION | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-222-15 | ML - Milliliter | 21695-222 | df822605-35fe-4273-83a6-18277fff83ca | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ACETIC ACID | ACTIVE INGREDIENT | Q40Q9N063P | ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| ACETIC ACID | ACTIVE MOIETY | Q40Q9N063P | ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| BENZETHONIUM CHLORIDE | INACTIVE INGREDIENT | PH41D05744 | ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLENE GLYCOL DIACETATE | INACTIVE INGREDIENT | 5Z492UNF9O | ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | ACETIC ACID SOLUTION [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197305 | acetic acid 2 % Otic Solution | PSN | a8c12387-4b2b-49c2-b9c5-112ffb133950 | 1 |
| 197305 | acetic acid 20 MG/ML Otic Solution | SCD | a8c12387-4b2b-49c2-b9c5-112ffb133950 | 1 |
| 197305 | acetic acid 2 % Otic Solution | SY | a8c12387-4b2b-49c2-b9c5-112ffb133950 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-222-15 | 21695022215 | 15 mL in 1 BOTTLE | 15 ml | Historical |