TopCare Antibacterial Plus Urinary Pain Relief

Product NDC
36800-314
Requested package NDC
36800-314-24
11-digit product format
368000314
Labeler code
36800
Product ID
36800-314_498de24d-a25d-44b9-a75d-596d77919f0c
Type
HUMAN OTC DRUG
Nonproprietary name
METHENAMINE, SODIUM SALICYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Topco Associates LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-02-22
Substance
METHENAMINE; SODIUM SALICYLATE
Active strength
162; 162.5 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage36800-31436800-314-24IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage36800-31436800-314-24IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage36800-31436800-314-24IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

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
TopCare Antibacterial Plus Urinary Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHENAMINE162 mg/1
SODIUM SALICYLATE162.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J50OIX95QVInternal UNII lookup
WIQ1H85SYPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1489932Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
02af5576-d75c-4553-9431-9c482997c8bbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-314-242022-12-29C16284748780-1d6a99b39-d05d-a426-e053-dadaa90af4c202af5576-d75c-4553-9431-9c482997c8bb
36800-314-242022-01-28C16284748780-1d6a99b39-d05d-a426-e053-dadaa90af4c202af5576-d75c-4553-9431-9c482997c8bb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-314-24TopCare Antibacterial Plus Urinary Pain Relief1 in 1 CARTONTABLET13
36800-314-24TopCare Antibacterial Plus Urinary Pain Relief24 in 1 BLISTER PACKTABLET243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-314TOPCARE ANTIBACTERIAL PLUS URINARY PAIN RELIEF (METHENAMINE, SODIUM SALICYLATE) TABLET [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 2 package rows20241220_02af5576-d75c-4553-9431-9c482997c8bb.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Antibacterial Plus Urinary Pain ReliefMETHENAMINE, SODIUM SALICYLATETopco Associates LLC02af5576-d75c-4553-9431-9c482997c8bb2024-12-18WarningsExact identifier
ndc (package): 36800-314-24
ndc (product): 36800-314
ndc11 (package): 36800031424

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletPSN02af5576-d75c-4553-9431-9c482997c8bb3
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletSCD02af5576-d75c-4553-9431-9c482997c8bb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-314-24368000314241 BLISTER PACK in 1 CARTON (36800-314-24) / 24 TABLET in 1 BLISTER PACK1 blister pack2017-02-220000-00-00NoNoCurrent