FDA.reportPublic FDA data

Northside Hospital Mothers Vaginal

Product NDC
59448-211
11-digit product format
594480211
Labeler code
59448
Product ID
59448-211_22b3c28b-1264-4afb-90da-dbc55a79ab89
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL and SODIUM MONOFLUOROPHOSPHATE
Dosage form
KIT
Labeler
ASP Global, LLc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-02
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Northside Hospital Mothers Vaginal
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7f1a85fd-086b-4fc7-abac-863dd3ea505aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-001-02Northside Hospital Mothers Vaginal53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL2
59448-211-00Northside Hospital Mothers Vaginal1 in 1 BAGKIT12
59448-211-00Northside Hospital Mothers Vaginal6 in 1 BOXKIT62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-211NORTHSIDE HOSPITAL MOTHERS VAGINAL (ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]2Current NDC, Legacy NDC, 3 package rows20250101_7f1a85fd-086b-4fc7-abac-863dd3ea505a.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 113 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.416267f2-85c5-6633-e054-00144ff8d46c2023-11-03WarningsExact identifier
application number: M003
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
application number: M003
POVIDONE-IODINE PAD- povidone-iodine swabPOVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)Raya Pharmaceuticals LLCdbcbd1be-5274-3de3-e053-2995a90abf1c2023-10-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
application number: M003
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0c0-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0af-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08bf-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5726f-d314-50d9-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08ad-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c7f9a00-6600-4b0d-af11-fa776b22e6782023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd1c9f2c8b-6ed6-4e54-a151-5be4acb290e42023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltd878bfaa7-d553-40db-8311-19010930abd92023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc1273e40-5c09-435b-adf3-e352fdd01e9e2023-10-23WarningsExact identifier
application number: M003
POVIDONE IODINE SCRUB SWABSTICK 3sPOVIDONE-IODINEJianerkang Medical Co., Ltd65783da9-acca-41c7-860b-1de108edc5832023-10-23WarningsExact identifier
application number: M003
Obstetrical ToweletteBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd8db4eb14-85b6-4c8e-9623-39a43b3827a12023-10-23WarningsExact identifier
application number: M003
POVIDONE IODINE PREP PAD SterilePOVIDONE-IODINEJianerkang Medical Co., Ltdac3aa401-a124-4eb7-9598-119be0f24ddd2023-10-23WarningsExact identifier
application number: M003
Alcohol Prep PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc13af96e-f76a-4577-8d57-811ccc6527382023-10-23WarningsExact identifier
application number: M003
Povidone-Iodine Prep PadPOVIDONE-IODINECardinal Health 200, Inc.06c8a6f6-2fc8-4292-a3b5-6311a918a5212023-10-23WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN7f1a85fd-086b-4fc7-abac-863dd3ea505a2
545626sodium monofluorophosphate 0.76 % ToothpastePSN7f1a85fd-086b-4fc7-abac-863dd3ea505a2
581660ethanol 0.62 ML/ML Topical GelSCD7f1a85fd-086b-4fc7-abac-863dd3ea505a2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD7f1a85fd-086b-4fc7-abac-863dd3ea505a2
581660ethanol 62 % Topical GelSY7f1a85fd-086b-4fc7-abac-863dd3ea505a2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY7f1a85fd-086b-4fc7-abac-863dd3ea505a2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY7f1a85fd-086b-4fc7-abac-863dd3ea505a2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY7f1a85fd-086b-4fc7-abac-863dd3ea505a2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY7f1a85fd-086b-4fc7-abac-863dd3ea505a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-001-025944800010253 mL in 1 BOTTLE, PLASTIC53 mlHistorical
59448-211-00594480211006 BAG in 1 BOX (59448-211-00) / 1 KIT in 1 BAG * 4.25 g in 1 TUBE * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 10 g in 1 TUBE (42555-060-45) * 53 mL in 1 BOTTLE, PLASTIC (59448-001-02) * 65 mL in 1 BOTTLE, PLASTIC6 bag2022-12-020000-00-00NoNoCurrent