FDA.reportPublic FDA data

NDC 51079-077-01 - 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
51079-077
Requested NDC
51079-077-01
Package NDCs from labels
51079-077-01, 51079-077-20
Manufacturer
Cardinal Health | UDL Laboratories, Inc.
Effective date
2020-07-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HydrOXYzine Pamoate Capsules USPCardinal Health | UDL Laboratories, Inc.2020-07-10HUMAN PRESCRIPTION DRUG LABEL
HydrOXYzine Pamoate Capsules USPMylan Institutional Inc.2019-12-30HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-077-01EA - Each51079-07790b11822-c91f-4206-b05e-20dd06d2639212013-02-13
51079-077-20EA - Each51079-07708dff23c-02f8-4a98-a963-93bc98bebed712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [CARDINAL HEALTH]5
HYDROXYZINE PAMOATEACTIVE INGREDIENTM20215MUFRHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
HYDROXYZINEACTIVE MOIETY30S50YM8OGHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
GELATININACTIVE INGREDIENT2G86QN327LHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHYDROXYZINE PAMOATE CAPSULE [MYLAN INSTITUTIONAL INC.]4

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 1 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: LMI26O6933
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Vac-ChordALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM.Energetix Corporation880ea1e6-8d4d-486e-9a8f-9d3158a996672026-08-11WarningsExact identifier
unii: LMI26O6933
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: LMI26O6933

Reported adverse events (FAERS/openFDA)#

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