FDA.reportPublic FDA data

NDC 70518-2279-00 - Hydroxyzine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70518-2279
Requested NDC
70518-2279-00
Package NDCs from labels
70518-2279-0, 70518-2279-1, 70518-2279-2, 70518-2279-3, 70518-2279-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
hydrOXYzine Hydrochloride Tablets, USPREMEDYREPACK INC.2026-07-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2279-0Hydroxyzine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3016
70518-2279-1Hydroxyzine Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED3016
70518-2279-2Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3016
70518-2279-3Hydroxyzine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2279HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 4 package rows20250309_ca67c061-c743-4ebb-a9d5-ece488060663.zip

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 140 · 2,785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
HeadacheMELILOTUS OFFICINALIS, SPIGELIA ANTHELMIA, ALLIUM CEPA, BELLADONNA, BRYONIA (ALBA), CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, SANGUINARIA CANADENSIS, SILICEA, TARENTULA CUBENSISBioActive Nutritionals, Inc.918bc478-78a2-41e1-b123-f5350cf8f43a2026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDESt Mary's Medical Park Pharmacy9ef6a4b7-362d-61b4-e053-2995a90a0ebb2026-07-28Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutions5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca2026-07-24Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy30b6f7b3-b620-961a-e063-6394a90a487b2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.ca67c061-c743-4ebb-a9d5-ece4880606632026-07-22Warnings, Adverse reactionsExact identifier
application number: ANDA088618
ndc (package): 70518-2279-0
ndc (package): 70518-2279-2
ndc (package): 70518-2279-1
ndc (package): 70518-2279-3
ndc (product): 70518-2279
ndc11 (package): 70518227900
rxcui: 995258
spl id: 57342f6a-9730-3aaf-e063-6294a90a44b5
spl set id: ca67c061-c743-4ebb-a9d5-ece488060663
unii: 76755771U3
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
HYDROXYZINE HYDROCHLORIDEHYDROXYZINE HYDROCHLORIDEAPOZEAL PHARMACEUTICALS INC87d4bbff-0498-4c26-86cb-7ce173afa0b62026-07-21Warnings, Adverse reactionsExact identifier
unii: 76755771U3
HydrOXYzine HydrochlorideHYDROXYZINE HYDROCHLORIDEA-S Medication Solutionsbe6a2f09-c0f3-44e2-aac3-37e3702b93f02026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 995281
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDECardinal Health 107, LLCb4d274ce-d616-4835-80ce-76270524ed362026-07-20Warnings, Adverse reactionsExact identifier
application number: ANDA088618
rxcui: 995258
unii: 76755771U3
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEMajor Pharmaceuticals7f76580c-96a0-4b56-8986-ff5488bb98692026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 995218
rxcui: 995281
rxcui: 995258
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.bb4a7d22-2f42-4e9f-bf98-cee43ed14d502026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 995281
unii: 76755771U3
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEPreferred Pharmaceuticals Incc8b441bf-a03e-47b3-8f06-c347f5ca4b702026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 995218
unii: 76755771U3
Hydroxyzine hydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.b6189074-e199-4f58-a78d-c04f131c13d92026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3
Hydroxyzine HydrochlorideHYDROXYZINE HYDROCHLORIDEREMEDYREPACK INC.aa9523e0-c95d-4213-b213-96170d8555362026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 995258
unii: 76755771U3