FDA.reportPublic FDA data

NDC 65862-600-06 - RIZATRIPTAN BENZOATE

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
65862-600
Requested NDC
65862-600-06
Package NDCs from labels
65862-600-03, 65862-600-90, 65862-600-12, 65862-600-06, 65862-600-18
Manufacturer
DIRECT RX
Effective date
2026-03-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RIZATRIPTAN BENZOATE - DIRECT RXDIRECT RX2026-03-17HUMAN PRESCRIPTION DRUG LABEL
Rizatriptan Benzoate - Aurobindo Pharma LimitedAurobindo Pharma Limited2024-02-17Human Prescription Drug Label
Rizatriptan Benzoate - Proficient Rx LPProficient Rx LP2022-05-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-600-03Rizatriptan Benzoate3 in 1 BLISTER PACKTABLET314
65862-600-06Rizatriptan Benzoate6 in 1 BLISTER PACKTABLET614
65862-600-12Rizatriptan Benzoate4 in 1 CARTONTABLET414
65862-600-18Rizatriptan Benzoate3 in 1 CARTONTABLET314
65862-600-90Rizatriptan Benzoate3 in 1 CARTONTABLET314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-600RIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 5 package rows20240218_fa0f65b8-96b0-49e4-ac47-9a86fb4aa5f1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-600-03EA - Each65862-6007ea2a346-4cdc-463c-a0bb-a392009716ad12013-02-13
65862-600-12EA - Each65862-60056ce3e0e-3e92-4136-8ee7-a9899a6ac6f112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIZATRIPTAN BENZOATEACTIVE INGREDIENTWR978S7QHHRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
RIZATRIPTANACTIVE MOIETY51086HBW8GRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIZATRIPTAN BENZOATE TABLET [AUROBINDO PHARMA LIMITED]3

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 15 of 36 · 706 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
unii: 1K09F3G675
FARGELIN HEMORRHOIDALCALAMINE, PETROLATUM AND PHENYLEPHRINE HYDROCHLORIDEMADISON ONE ACME INC6844ad63-512d-496a-9458-011894185b0d2025-11-10WarningsExact identifier
unii: 1K09F3G675
LUMOe SKIN1 Skin RemedyKALI MURIATICUM, PRUNUS SPINOSA, SILICEA, SARSAPARILLAApplied Bioenergetics, LLCd4d7fd2f-66bf-407d-ad36-2462e880b9f52025-11-10WarningsExact identifier
unii: ETJ7Z6XBU4
Ananassa ResinaANANASSA RESINAUriel Pharmacy Inc.52a18d0a-2c97-4e81-81ff-c836582d0a4c2025-11-07WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
unii: 1K09F3G675
Rizatriptan BenzoateRIZATRIPTAN BENZOATEBryant Ranch Prepack6391d2a1-252e-4e50-9d80-4dce12eabc8f2025-11-06Warnings, Adverse reactionsExact identifier
rxcui: 312840
unii: WR978S7QHH
Rizatriptan BenzoateRIZATRIPTAN BENZOATEA-S Medication Solutions187204ef-5370-476a-84b1-e3c54b60c6c22025-11-06Warnings, Adverse reactionsExact identifier
application number: ANDA202490
rxcui: 314209
unii: WR978S7QHH
RizatriptanRIZATRIPTANA-S Medication Solutions34395ed2-97b7-4220-9089-0e90169d30832025-11-05Warnings, Adverse reactionsExact identifier
rxcui: 314209
unii: WR978S7QHH
Calamine Plus Pramoxine HClCALAMINE PLUS NO TOUCH SPRAYPremier Brands of America Inc.36481d67-2346-470b-e063-6294a90aae992025-11-03WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
unii: 1K09F3G675
REMEDY Calazime Skin ProtectantCALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP1295cfcc-5b61-481b-964b-f53ffd0cb58e2025-10-30WarningsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
unii: 1K09F3G675
Aveeno Anti-Itch ConcentratedZINC OXIDE, FERRIC OXIDE RED, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC07f4d4d0-9cee-46c3-bc71-2024abd31c9e2025-10-29WarningsExact identifier
unii: 1K09F3G675
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYPremier Brands of America, Inc.d3452573-f91f-f157-e053-2a95a90a1ad82025-10-27WarningsExact identifier
unii: 1K09F3G675
Miranda Castros Healing Cell Salts For Bones, Hair, Nails, and TeethCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAMIRANDA CASTRO'S SHOP, LLC267fb775-a03c-f100-e063-6394a90aa8262025-10-23WarningsExact identifier
unii: ETJ7Z6XBU4
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic CombinationCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAMIRANDA CASTRO'S SHOP, LLC266e907b-4cdb-fb4f-e063-6394a90aa4342025-10-23WarningsExact identifier
unii: ETJ7Z6XBU4
Rizatriptan BenzoateRIZATRIPTAN BENZOATEAdvanced Rx of Tennessee, LLC4137a02e-dcec-c14c-e063-6294a90aa44f2025-10-21Warnings, Adverse reactionsExact identifier
unii: WR978S7QHH
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICAATOSAFE CO., Ltd41196c2f-8e2e-a54d-e063-6294a90ad8a72025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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