Allergy Relief
- Product NDC
- 57344-194
- 11-digit product format
- 573440194
- Labeler code
- 57344
- Product ID
- 57344-194_dd2d0397-1615-a154-e053-2a95a90a6d25
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- AAA PHARMACEUTICAL, INC.
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2018-10-01
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Allergy Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014678 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57344-194-01 | Allergy Relief | 1 in 1 CARTON | TABLET, COATED | 1 | | 3 |
| 57344-194-01 | Allergy Relief | 14 in 1 BOTTLE, PLASTIC | TABLET, COATED | 14 | | 3 |
| 57344-194-14 | Allergy Relief | 30 in 1 BOTTLE, PLASTIC | TABLET, COATED | 30 | | 3 |
| 57344-194-14 | Allergy Relief | 1 in 1 CARTON | TABLET, COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57344-194 | ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, COATED [AAA PHARMACEUTICAL, INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20220422_ac22558b-5c82-4ab9-95b8-53eedea46282.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57344-194-01 | 57344019401 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-194-01) / 14 TABLET, COATED in 1 BOTTLE, PLASTIC | 2018-10-01 | 0000-00-00 | No | No | Current |
| 57344-194-14 | 57344019414 | 1 BOTTLE, PLASTIC in 1 CARTON (57344-194-14) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC | 2022-04-29 | 0000-00-00 | No | No | Current |