FDA.reportPublic FDA data

Histanaz

Product NDC
29978-129
11-digit product format
299780129
Labeler code
29978
Product ID
29978-129_5013a487-2901-ef02-e063-6394a90a2902
Type
HUMAN OTC DRUG
Nonproprietary name
Pseudoephedrine HCL, Pyrilamine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Capital Pharmaceutical, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-08
Substance
PSEUDOEPHEDRINE HYDROCHLORIDE; PYRILAMINE MALEATE
Active strength
60; 30 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Histanaz
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1
PYRILAMINE MALEATE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6V9V2RYJ8NInternal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2727351Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e87d0f3-f16c-5972-e063-6294a90acc8aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29978-129-10Histanaz100 in 1 BOTTLETABLET1002

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 162 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATEKroger1013ce02-7b12-335e-e063-6394a90af3e62024-05-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATEKroger10b08ea8-693e-eb18-e063-6394a90af5482024-05-08WarningsExact identifier
application number: M012
Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger10b0bcff-d3bc-f70c-e063-6394a90a35ed2024-05-08WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKroger10b0e0a0-b878-0a9a-e063-6394a90a20e02024-05-08WarningsExact identifier
application number: M012
Severe Cold and Flu Daytime HoneyACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKroger10b0fa3d-d6b2-272a-e063-6394a90a12052024-05-08WarningsExact identifier
application number: M012
Childrens Plus Multi Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWalgreensdd967cfb-96b4-4cdc-82e2-a4838001c9e32024-05-08WarningsExact identifier
application number: M012
Childrens Wal Tap Elixer Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreens3f438f28-d1ad-44da-a573-f1b0824b051c2024-05-08WarningsExact identifier
application number: M012
Cough Cold and Sore Throat ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens400a0998-e276-4c8d-9b41-145b1b405fff2024-05-08WarningsExact identifier
application number: M012
Mucus Congestion and Cough Relief ChildrensDEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCIWalgreens19cd2409-d56b-4319-833c-eacc7dc498c12024-05-08WarningsExact identifier
application number: M012
Severe Cold and Flu Nighttime HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger10b12f0e-dba7-fd71-e063-6294a90a42c12024-05-06WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATEKroger10b15337-b9c5-4dc8-e063-6394a90ac0562024-05-06WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKroger1014da86-3a0e-136f-e063-6294a90ac9312024-05-04WarningsExact identifier
application number: M012
Robitussin Honey Maximum Strength Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCeaa10aed-5b1e-48bf-bc05-7a5638851daf2024-05-03WarningsExact identifier
application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal DecongestantACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLCe35cb719-9e7d-4b2b-81a4-29e147dd74fa2024-05-03WarningsExact identifier
application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLC09e20842-2b75-43b9-ae5f-3515b35e655b2024-05-03WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)f958d8ba-ede9-4b1a-8317-2404b68a91292024-05-03WarningsExact identifier
application number: M012
Daytime Nighttime Cold and Flu Relief Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWinCo Foods, LLCfab57d70-ba54-416f-9f14-b64d2238ea162024-05-03WarningsExact identifier
application number: M012
Tussin CF Non Drowsy Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLC8ee27600-4f8e-406a-8ea3-eade691448f62024-05-03WarningsExact identifier
application number: M012
SanaTos Children Cough and Congestion CherryDEXTROMETHORPHAN HBR AND GUAIFENESINPharmadel LLC60437d86-9e13-8d8a-e053-2991aa0a23172024-05-02WarningsExact identifier
application number: M012
Robitussin Honey Maximum Strength Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC0b41da13-18a1-4987-ae43-1319bfa274842024-05-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2727351pseudoephedrine HCl 60 MG / pyrilamine maleate 30 MG Oral TabletPSN3e87d0f3-f16c-5972-e063-6294a90acc8a2
2727351pseudoephedrine hydrochloride 60 MG / pyrilamine maleate 30 MG Oral TabletSCD3e87d0f3-f16c-5972-e063-6294a90acc8a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
29978-129-1029978012910100 TABLET in 1 BOTTLE (29978-129-10) 100 tablet2025-09-08NoNoCurrent