FDA.reportPublic FDA data

STAHIST AD

Product NDC
58407-625
11-digit product format
584070625
Labeler code
58407
Product ID
58407-625_4041d3f9-d1cb-0931-e063-6394a90a82de
Type
HUMAN OTC DRUG
Nonproprietary name
CHLORCYCLIZINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Magna Pharmaceuticals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-12-20
Substance
CHLORCYCLIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
25; 60 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58407-625-3086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58407-625-0686f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58407-625-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58407-625-30bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58407-625-06bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58407-625-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58407-625-308dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58407-625-068dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58407-625-018dfbde2a14a4…c9ff85d89658…

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
STAHIST AD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORCYCLIZINE HYDROCHLORIDE25 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NPB7A7874UInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1235861Internal RxNorm lookup
1236716Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ccedbc38-2479-4c35-9f86-a9f29bcfab3fAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
58407-625-012023-11-06Stahist AD
58407-625-062023-11-06Stahist AD
58407-625-302023-11-06Stahist AD
58407-625-012023-07-28Stahist AD
58407-625-062023-07-28Stahist AD
58407-625-302023-07-28Stahist AD
58407-625-012022-08-17Stahist AD
58407-625-062022-08-17Stahist AD
58407-625-302022-08-17Stahist AD
58407-625-012021-01-29Stahist AD
58407-625-062021-01-29Stahist AD
58407-625-302021-01-29Stahist AD

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58407-625-01STAHIST AD1 in 1 BLISTER PACKTABLET18
58407-625-06STAHIST AD6 in 1 BOXTABLET68
58407-625-30STAHIST AD30 in 1 BOTTLETABLET308
58407-625-30STAHIST AD1 in 1 BOXTABLET18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58407-625-30EA - Each58407-6251514b49e-4e09-4f4f-bcde-62b65472665c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORCYCLIZINE HYDROCHLORIDEACTIVE INGREDIENTNPB7A7874USTAHIST AD (CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTICALS, INC.]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NSTAHIST AD (CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTICALS, INC.]1
CHLORCYCLIZINEACTIVE MOIETYM26C4IP44PSTAHIST AD (CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTICALS, INC.]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FSTAHIST AD (CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USTAHIST AD (CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30STAHIST AD (CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2STAHIST AD (CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58407-625STAHIST AD (CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [MAGNA PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 4 package rows20241207_ccedbc38-2479-4c35-9f86-a9f29bcfab3f.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 63 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Conex PediatricDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a46af43-ef36-e14e-e063-6394a90a82852025-12-31WarningsExact identifier
application number: M012
ConexDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a343656-ac6d-8b20-e063-6294a90ab3192025-12-31WarningsExact identifier
application number: M012
Dologesic NFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division974fc0d5-7a99-46fb-af38-b91240f728fa2025-12-31WarningsExact identifier
application number: M012
Dologesic DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division55768b45-fd98-4779-85b6-6a50c628677e2025-12-31WarningsExact identifier
application number: M012
TriponelDEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCLLlorens Pharmaceutical International Division, Inc.e9a8deb4-0595-4f0f-ac15-f936f15aca882025-12-31WarningsExact identifier
application number: M012
TusnelDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division805dc611-355a-4af5-bf19-464c3290c5c62025-12-31WarningsExact identifier
application number: M012
Tusnel PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division82f447f6-4f1b-4f56-9d7d-ea02adeea88c2025-12-31WarningsExact identifier
application number: M012
TriponelDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONcc774d33-96ce-4992-ad30-3cb03b0d119d2025-12-31WarningsExact identifier
application number: M012
Tusnel SFDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.cb43b4df-5ccc-416e-abcd-98f079b3f2bb2025-12-31WarningsExact identifier
application number: M012
Tusnel Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.af71cdbc-33d6-4303-b494-d7321721d3be2025-12-31WarningsExact identifier
application number: M012
Tusnel Pediatric DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLlorens Pharmaceutical International Division, Inc.63541753-de8d-42fe-a9b3-a5eac3fcdca42025-12-31WarningsExact identifier
application number: M012
Tusnel Pediatric DropsGUAIFENESIN, PHENYLEPHRINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONdbf7c43a-7b29-4c70-9e6d-8a7ea924a9d72025-12-31WarningsExact identifier
application number: M012
Tusnel DM PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Divisiond915eab8-013e-4ce3-b358-0d531e5ca1ba2025-12-31WarningsExact identifier
application number: M012
Tusnel-DM PediatricDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION64e36b02-b5be-4d20-8818-cb5b235966712025-12-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBestco Inc.77f89a64-f4a4-f909-e053-2a91aa0ad44d2025-12-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBestco Inc.77f65f59-7ea1-adce-e053-2991aa0a6f1f2025-12-31WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLBestco Inc.77f9e176-d87a-beed-e053-2991aa0aac202025-12-31WarningsExact identifier
application number: M012
Sugar Free Cherry Cough DropsMENTHOLBestco Inc.7858f380-bef7-3d30-e053-2a91aa0a7ea62025-12-31WarningsExact identifier
application number: M012
Strawberry Cough DropsMENTHOLBestCo Inc.26a22cfd-395b-4ffb-e054-00144ff88e882025-12-31WarningsExact identifier
application number: M012
Limpia PechoDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf32025-12-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235861chlorcyclizine HCl 25 MG / pseudoephedrine HCl 60 MG Oral TabletPSNccedbc38-2479-4c35-9f86-a9f29bcfab3f8
1236716Stahist AD 25 MG / 60 MG Oral TabletPSNccedbc38-2479-4c35-9f86-a9f29bcfab3f8
1236716chlorcyclizine hydrochloride 25 MG / pseudoephedrine hydrochloride 60 MG Oral Tablet [Stahist AD]SBDccedbc38-2479-4c35-9f86-a9f29bcfab3f8
1235861chlorcyclizine hydrochloride 25 MG / pseudoephedrine hydrochloride 60 MG Oral TabletSCDccedbc38-2479-4c35-9f86-a9f29bcfab3f8
1236716Stahist AD (chlorcyclizine hydrochloride 25 MG / pseudoephedrine hydrochloride 60 MG) Oral TabletSYccedbc38-2479-4c35-9f86-a9f29bcfab3f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58407-625-01584070625011 TABLET in 1 BLISTER PACK (58407-625-01) 1 tablet2019-09-010000-00-00NoNoCurrent
58407-625-06584070625066 BLISTER PACK in 1 BOX (58407-625-06) / 1 TABLET in 1 BLISTER PACK (58407-625-01) 6 blister pack2011-12-200000-00-00NoNoCurrent
58407-625-30584070625301 BOTTLE in 1 BOX (58407-625-30) / 30 TABLET in 1 BOTTLE1 bottle2011-12-200000-00-00NoNoCurrent