Urin

Product NDC
54859-701
11-digit product format
548590701
Labeler code
54859
Product ID
54859-701_30ac92c0-60aa-4b0f-82f0-5a17f62f3702
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine, Sodium Phosphate, Monobasic, Monohydrate, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Llorens Pharmaceutical International Division
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1999-05-01
Marketing end
0000-00-00
Substance
METHENAMINE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE
Active strength
82 mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210
c39b72c3-7732-4ed2-a995-e6aa3a665a54Product name320250819
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54859-701-042019-11-27C16284748780-19855e2a2-4431-60a7-e053-dbdaa90a05bd6368bb69-43e9-4304-a30d-03d593c1c05f
54859-701-102019-11-27C16284748780-19855e2a2-4431-60a7-e053-dbdaa90a05bd6368bb69-43e9-4304-a30d-03d593c1c05f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-701-04UrinD/S4 in 1 BOTTLETABLET44
54859-701-10UrinD/S100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-701-10EA - Each54859-70134712066-9273-4a45-af91-9f337bd9132e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hyoscyamine SulfateACTIVE INGREDIENTF2R8V82B84URIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
MethenamineACTIVE INGREDIENTJ50OIX95QVURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
Methylene BlueACTIVE INGREDIENTT42P99266KURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
Phenyl SalicylateACTIVE INGREDIENT28A37T47QOURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEACTIVE INGREDIENT593YOG76RNURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
HyoscyamineACTIVE MOIETYPX44XO846XURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
MethenamineACTIVE MOIETYJ50OIX95QVURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
METHYLENE BLUE CATIONACTIVE MOIETYZMZ79891ZHURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
Phenyl SalicylateACTIVE MOIETY28A37T47QOURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
Sodium CationACTIVE MOIETYLYR4M0NH37URIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208URIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30URIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
TALCINACTIVE INGREDIENT7SEV7J4R1UURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPURIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4
TRIACETININACTIVE INGREDIENTXHX3C3X673URIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-701URIN D/S (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]4Legacy NDC, 2 package rows20140610_6368bb69-43e9-4304-a30d-03d593c1c05f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047786hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG / sodium phosphate, monobasic 40.8 MG Oral TabletPSN6368bb69-43e9-4304-a30d-03d593c1c05f4
1547952hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG / sodium phosphate, monobasic 40.8 MG Oral Tablet [Urin DS]SBD6368bb69-43e9-4304-a30d-03d593c1c05f4
1047786hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG / sodium phosphate, monobasic 40.8 MG Oral TabletSCD6368bb69-43e9-4304-a30d-03d593c1c05f4
1547952Urin DS (hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG / sodium phosphate, monobasic 40.8 MG) Oral TabletSY6368bb69-43e9-4304-a30d-03d593c1c05f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54859-701-04548590701044 in 1 BOTTLEHistorical
54859-701-1054859070110100 in 1 BOTTLEHistorical