ZYRTEC
- Product NDC
- 50580-779
- 11-digit product format
- 505800779
- Labeler code
- 50580
- Product ID
- 50580-779_cea20e63-c9ab-38c7-e053-2995a90adebe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
- Application
- NDA022429
- Marketing category
- NDA
- Marketing start
- 2010-02-08
- Marketing end
- 0000-00-00
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Cetirizine Hydrochloride | ACTIVE INGREDIENT | 64O047KTOA | ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 4 | |
| Cetirizine | ACTIVE MOIETY | YO7261ME24 | ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 4 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 4 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 4 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 4 | |
| polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 4 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 4 | |
| sorbitan | INACTIVE INGREDIENT | 6O92ICV9RU | ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 4 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 4 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-779 | ZYRTEC (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC] | 13 | Legacy NDC | 20241109_605adf29-734f-451a-8ff3-74be7b5814a6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50580-779-12 | 50580077912 | 1 BOTTLE in 1 PACKAGE (50580-779-12) > 12 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2010-02-08 | 0000-00-00 | No | No | Current |
| 50580-779-25 | 50580077925 | 1 BOTTLE in 1 PACKAGE (50580-779-25) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2010-02-08 | 0000-00-00 | No | No | Current |
| 50580-779-40 | 50580077940 | 1 BOTTLE in 1 PACKAGE (50580-779-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2010-02-08 | 0000-00-00 | No | No | Current |
| 50580-779-65 | 50580077965 | 65 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-779-65) | | 2010-02-08 | 0000-00-00 | No | No | Current |