FDA.reportPublic FDA data

NDC 70518-3452-2 - hydroxyzine pamoate

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
70518-3452
Requested NDC
70518-3452-2
Package NDCs from labels
70518-3452-0, 70518-3452-1, 70518-3452-2, 70518-3452-3, 70518-3452-4
Manufacturer
REMEDYREPACK INC.
Effective date
2024-10-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rx onlyREMEDYREPACK INC.2024-10-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3452HYDROXYZINE PAMOATE CAPSULE [REMEDYREPACK INC.]8Legacy NDC20241006_6a359732-3e2b-4ea8-84df-60ae4024b3dc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 25 of 142 · 2,838 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WalmartISOPROPYL ALCOHOLWalmart Inc.1d75799d-081e-a38b-e063-6294a90adf352026-01-29WarningsExact identifier
unii: ND2M416302
IRISISOPROPYL ALCOHOLAmerifoods Trading Co100e0c3d-96eb-44af-8684-df45a8ab30652026-01-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLBig Lots Stores, Inc.2c941c08-929c-43c9-966b-279086afca962026-01-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLBig Lots Stores, Inc.2ef87a8a-58be-4123-ad03-9891e6916f1a2026-01-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLCariba International001c1fcf-2808-467c-86d8-c038513fa3b52026-01-29WarningsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLCariba International483586f4-aab4-40c2-8925-c4f7fb22c6aa2026-01-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
SHISEIDO SPORTS BB DARKOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONf4fc4b6a-9507-496e-9ecb-8400055ecf2d2026-01-28WarningsExact identifier
unii: 15FIX9V2JP
Hampton Sun SPF 30 MineralZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCb8ee428e-07d3-4c6c-853c-cfbe3e4002d92026-01-28WarningsExact identifier
unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen AmalfiCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFILE COSMETICS INC4963658b-59bb-b313-e063-6394a90a0a512026-01-27WarningsExact identifier
unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen RioCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIOLE COSMETICS INC49644002-153f-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaboCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABOLE COSMETICS INC49643a56-3627-67f8-e063-6294a90a2d7b2026-01-27WarningsExact identifier
unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaymansCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANSLE COSMETICS INC49644002-153e-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
unii: 15FIX9V2JP
Singular Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCac2b352f-6cb2-4683-bb41-13e8ecb186bf2026-01-27WarningsExact identifier
unii: ND2M416302
SURFERS BARRIER SPF 50ZINC OXIDE, TITANIUM DIOXIDEAvasol LLCec55eef0-17e6-416d-bd5e-548f2f323cea2026-01-26WarningsExact identifier
unii: 15FIX9V2JP
Snap Labs Ammonia InhalantsAMMONIA INHALANTBrined LLC d/b/a Snap Labs4927c18f-078e-94ec-e063-6394a90a4c6d2026-01-24WarningsExact identifier
unii: 5138Q19F1X
Everlit Survival Sting Relief PadISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a0414ea-f862-aa0f-e063-6294a90aecb72026-01-23WarningsExact identifier
unii: ND2M416302
EVERLIT SURVIVAL PREP PADISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a03ed81-5b1d-172e-e063-6394a90ac59c2026-01-23WarningsExact identifier
unii: ND2M416302
ISA KNOX 365 BB SUNSCREEN Broad Spectrum SPF 40, PATITANIUM DIOXIDELG Household and Healthcare, Inc.65e70306-9e79-494d-9217-a43002f163072026-01-23WarningsExact identifier
unii: 15FIX9V2JP
O HUI Sun Science Ideal Cover Sunscreen Broad SpectrumTITANIUM DIOXIDELG Household and Healthcare, Inc.c15ffd23-271d-458d-9048-9bc50331d5d72026-01-23WarningsExact identifier
unii: 15FIX9V2JP
hydroxyzine pamoateHYDROXYZINE PAMOATEPreferred Pharmaceuticals Inc.b903f7e1-250d-46d8-a1ec-3f1dabc597f12026-01-23Warnings, Adverse reactionsExact identifier
application number: ANDA201507
rxcui: 995278
unii: M20215MUFR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.