NDC 35418-111-68 - Histenol Forte II

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
35418-111
Requested NDC
35418-111-68
Package NDCs from labels
35418-111-02, 35418-111-68, 35418-111-67
Manufacturer
Zee Medical Inc | Ultra Seal Corporation | Ultratab Laboratories, Inc.
Effective date
2023-01-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsZee Medical Inc | Ultra Seal Corporation | Ultratab Laboratories, Inc.2023-01-06HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35418-111-672023-01-06C16284748780-1ba0f9c33-51d7-a910-e053-dadaa90a0b85Drug Facts
35418-111-672021-01-29C16284748780-1ba0f9c33-51d7-a910-e053-dadaa90a0b85Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
GUAIFENESINACTIVE MOIETY495W7451VQHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APHISTENOL FORTE II (PHENYLEPHRINE HCL, ACETAMINOPHEN, GUAIFENESIN) TABLET [ZEE MEDICAL INC]1

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 248 · 4,958 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company1022767d-a456-4fbc-95cf-91337c74c3302026-10-01WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
unii: 362O9ITL9D
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporation7f445de3-30cf-4bd8-892d-05979cd399e72026-09-09WarningsExact identifier
unii: 362O9ITL9D
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: 362O9ITL9D
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsExact identifier
unii: 495W7451VQ
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsExact identifier
unii: 495W7451VQ
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
unii: 495W7451VQ
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
Maximum Strength Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC5a6f88b8-3436-3321-e063-6294a90a3a2e2026-09-09WarningsExact identifier
unii: 495W7451VQ
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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