Allergy Relief
- Product NDC
- 83324-091
- 11-digit product format
- 833240091
- Labeler code
- 83324
- Product ID
- 83324-091_1fd10ca6-5ab4-50d2-e063-6294a90a3a09
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- CHAIN DRUG MARKETING ASSOCIATION, INC.
- Application
- ANDA209274
- Marketing category
- ANDA
- Marketing start
- 2024-08-16
- 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
openFDA Listing Details
- Product ID
- 83324-091_1fd10ca6-5ab4-50d2-e063-6294a90a3a09
- SPL ID
- 1fd10ca6-5ab4-50d2-e063-6294a90a3a09
- Product type
- HUMAN OTC DRUG
- Finished product
- Yes
- Brand name base
- Allergy Relief
- Generic name
- Cetirizine hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Marketing start
- 2024-08-16
- Marketing category
- ANDA
- Application number
- ANDA209274
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Antagonist [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014678 |
| Spl Set Id | 6eb22b5a-ff30-44f8-aca2-3f73614515a8 |
| Manufacturer Name | CHAIN DRUG MARKETING ASSOCIATION, INC. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 83324-091-14 | 1 BOTTLE, PLASTIC in 1 CARTON (83324-091-14) / 14 TABLET, COATED in 1 BOTTLE, PLASTIC | 2024-08-16 | No |
| 83324-091-30 | 1 BOTTLE, PLASTIC in 1 CARTON (83324-091-30) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC | 2024-08-16 | No |
| 83324-091-90 | 1 BOTTLE, PLASTIC in 1 CARTON (83324-091-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC | 2024-08-17 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 64O047KTOA | CETIRIZINE HYDROCHLORIDE | 83881-52-1 | CETIRIZINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83324-091-14 | 83324009114 | 1 BOTTLE, PLASTIC in 1 CARTON (83324-091-14) / 14 TABLET, COATED in 1 BOTTLE, PLASTIC | 2024-08-16 | No | No | Historical |
| 83324-091-30 | 83324009130 | 1 BOTTLE, PLASTIC in 1 CARTON (83324-091-30) / 30 TABLET, COATED in 1 BOTTLE, PLASTIC | 2024-08-16 | No | No | Historical |
| 83324-091-90 | 83324009190 | 1 BOTTLE, PLASTIC in 1 CARTON (83324-091-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC | 2024-08-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| 1194A-QCH-2024-0816 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 2024-08-16 | HUMAN OTC DRUG LABEL | 2 |