TopCare Childrens All Day Allergy
- Product NDC
- 36800-475
- 11-digit product format
- 368000475
- Labeler code
- 36800
- Product ID
- 36800-475_11d505ff-696b-462c-8952-0c73491de9f4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA204226
- Marketing category
- ANDA
- Marketing start
- 2016-02-02
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 5 mg/5mL
- 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
- TopCare Childrens All Day Allergy
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CETIRIZINE HYDROCHLORIDE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 64O047KTOA |
| Rxcui | 1014673 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-475-00 | TopCare Childrens All Day Allergy | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
| 36800-475-00 | TopCare Childrens All Day Allergy | 240 mL in 1 BOTTLE | SOLUTION | 240 | | 4 |
| 36800-475-26 | TopCare Childrens All Day Allergy | 1 in 1 CARTON | SOLUTION | 1 | | 4 |
| 36800-475-26 | TopCare Childrens All Day Allergy | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-475 | TOPCARE CHILDRENS ALL DAY ALLERGY (CETIRIZINE HCL) SOLUTION [TOPCO ASSOCIATES LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20250501_48555c1f-8c2a-4ab2-9af3-d2488ca509e4.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 |
|---|
| 36800-475-00 | 36800047500 | 1 BOTTLE in 1 CARTON (36800-475-00) / 240 mL in 1 BOTTLE | 1 bottle | 2021-11-01 | 0000-00-00 | No | No | Current |
| 36800-475-26 | 36800047526 | 1 BOTTLE in 1 CARTON (36800-475-26) / 118 mL in 1 BOTTLE | 1 bottle | 2016-02-02 | 0000-00-00 | No | No | Current |