Childrens Zyrtec
- Product NDC
- 50580-730
- 11-digit product format
- 505800730
- Labeler code
- 50580
- Product ID
- 50580-730_40cb0507-49ef-8320-e063-6294a90ae39f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- NDA022155
- Marketing category
- NDA
- Marketing start
- 2009-06-01
- 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
- Childrens Zyrtec
- 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, 1020021 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Cetirizine Hydrochloride | ACTIVE INGREDIENT | 64O047KTOA | CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| Cetirizine | ACTIVE MOIETY | YO7261ME24 | CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| sucralose | INACTIVE INGREDIENT | 96K6UQ3ZD4 | CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-730 | CHILDRENS ZYRTEC (CETIRIZINE HYDROCHLORIDE) SYRUP [KENVUE BRANDS LLC] | 16 | Current NDC, Legacy NDC, 12 package rows | 20250522_9d8e78ea-af98-4f7c-8db5-044b49582f80.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 |
|---|
| 50580-730-01 | 50580073001 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-01) / 30 mL in 1 BOTTLE, PLASTIC | | 2017-01-16 | 0000-00-00 | No | No | Current |
| 50580-730-05 | 50580073005 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-05) / 118 mL in 1 BOTTLE, PLASTIC | | 2015-07-13 | 0000-00-00 | No | No | Current |
| 50580-730-06 | 50580073006 | 2 CARTON in 1 PACKAGE (50580-730-06) / 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC | 2 carton | 2015-07-31 | 0000-00-00 | No | No | Current |
| 50580-730-17 | 50580073017 | 3 TRAY in 1 PACKAGE (50580-730-17) / 1 BOTTLE in 1 TRAY / 118 mL in 1 BOTTLE | 3 tray | 2018-12-03 | 0000-00-00 | No | No | Current |
| 50580-730-18 | 50580073018 | 2 CARTON in 1 PACKAGE (50580-730-18) / 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE | 2 carton | 2018-12-03 | 0000-00-00 | No | No | Current |
| 50580-730-19 | 50580073019 | 1 BOTTLE, PLASTIC in 1 CARTON (50580-730-19) / 240 mL in 1 BOTTLE, PLASTIC | | 2020-06-16 | 0000-00-00 | No | No | Current |