Home NDC 55315-354-31 CHILDRENS ALLERGY RELIEF
Product NDC 55315-354
Requested package NDC 55315-354-31
11-digit product format 553150354
Labeler code 55315
Product ID 55315-354_17d2db07-4de0-4e02-8e2e-0082c275faab
Type HUMAN OTC DRUG
Nonproprietary name Cetirizine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Fred's, Inc.
Application ANDA090750
Marketing category ANDA
Marketing start 2015-01-31
Substance CETIRIZINE HYDROCHLORIDE
Active strength 1 mg/mL
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090750-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-02-02 A090750-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION / ORAL 2010-02-02
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A090750-001 CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF 5MG/5ML SOLUTION / ORAL 2010-02-02 a50c72e98297…2026-08-01 22:54:32 2026-06 A090750-002 CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY 5MG/5ML SOLUTION / ORAL 2010-02-02 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 6 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base CHILDRENS ALLERGY RELIEF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CETIRIZINE HYDROCHLORIDE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 64O047KTOA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1014673 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55315-354-31 CHILDRENS ALLERGY RELIEF 120 mL in 1 BOTTLE SOLUTION 120 5 55315-354-31 CHILDRENS ALLERGY RELIEF 1 in 1 CARTON SOLUTION 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CETIRIZINE HYDROCHLORIDE ACTIVE INGREDIENT 64O047KTOA CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.] 1 CETIRIZINE ACTIVE MOIETY YO7261ME24 CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.] 1 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.] 1 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55315-354 CHILDRENS ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) SOLUTION [FRED'S, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20201215_55e799b2-e325-4286-aa9a-b88e99ab1146.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 55315-354-31 55315035431 1 BOTTLE in 1 CARTON (55315-354-31) / 120 mL in 1 BOTTLE 1 bottle 2015-01-31 0000-00-00 No No Current