Hyophen

Product NDC
0076-0901
11-digit product format
000760901
Labeler code
0076
Product ID
0076-0901_45640779-4ba0-45fd-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
Dosage form
TABLET
Route
ORAL
Labeler
Star Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2010-09-21
Marketing end
0000-00-00
Substance
METHENAMINE; BENZOIC ACID; PHENYL SALICYLATE; METHYLENE BLUE; HYOSCYAMINE SULFATE
Active strength
82 mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Ammonium Ion Binding Activity [MoA],Nitrogen Binding Agent [EPC],Oxidation-Reduction Activity [MoA],Oxidation-Reduction Agent [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0076-0901-012020-01-31C16284748780-19d75b9d0-43f3-f424-e053-dadaa90a57ceHyophen ™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0076-0901-01Hyophen100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0076-0901-01EA - Each0076-090151e285b1-6772-46d7-a3a8-0668eea150c112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzoic AcidACTIVE INGREDIENT8SKN0B0MIMHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Hyoscyamine SulfateACTIVE INGREDIENTF2R8V82B84HYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
MethenamineACTIVE INGREDIENTJ50OIX95QVHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Methylene BlueACTIVE INGREDIENTT42P99266KHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Phenyl SalicylateACTIVE INGREDIENT28A37T47QOHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Benzoic AcidACTIVE MOIETY8SKN0B0MIMHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
HyoscyamineACTIVE MOIETYPX44XO846XHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
MethenamineACTIVE MOIETYJ50OIX95QVHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Methylene BlueACTIVE MOIETYT42P99266KHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Phenyl SalicylateACTIVE MOIETY28A37T47QOHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
CrospovidoneINACTIVE INGREDIENT68401960MKHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30HYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Polyethylene GlycolINACTIVE INGREDIENT3WJQ0SDW1AHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Polyvinyl AlcoholINACTIVE INGREDIENT532B59J990HYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4HYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2HYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Starch, RiceINACTIVE INGREDIENT4DGK8B7I3SHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
TalcINACTIVE INGREDIENT7SEV7J4R1UHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPHYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0076-0901HYOPHEN (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [STAR PHARMACEUTICALS, LLC]7Legacy NDC, 1 package rows20170106_2c1f0f4c-e57b-4df5-9a58-41d39c3d8893.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037236Hyophen 81.6 MG / 9 MG / 36.2 MG / 10.8 MG / 0.12 MG Oral TabletPSN2c1f0f4c-e57b-4df5-9a58-41d39c3d88937
1037234methenamine 81.6 MG / phenyl salicylate 36.2 MG / methylene blue 10.8 MG / benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG Oral TabletPSN2c1f0f4c-e57b-4df5-9a58-41d39c3d88937
1037236benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG Oral Tablet [Hyophen]SBD2c1f0f4c-e57b-4df5-9a58-41d39c3d88937
1037234benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG Oral TabletSCD2c1f0f4c-e57b-4df5-9a58-41d39c3d88937
1037236Hyophen (benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG) Oral TabletSY2c1f0f4c-e57b-4df5-9a58-41d39c3d88937

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0076-0901-0100076090101100 in 1 BOTTLEHistorical