FDA.reportPublic FDA data

Allergy Relief

Product NDC
70000-0160
11-digit product format
700000160
Labeler code
70000
Product ID
70000-0160_cad6c859-0a91-4d1a-be53-1b702ec8efce
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 110, LLC. DBA Leader
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-12-19
Substance
CHLORPHENIRAMINE MALEATE
Active strength
4 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-016070000-0160-1DDiscontinued by firm2026-10-27

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70000-016070000-0160-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70000-016070000-0160-1DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
Allergy Relief
Brand name suffix
4 Hour
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1363309Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
aaecfda5-1a50-4d8a-9909-7153c1a22bdaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0160-1Allergy Relief4 Hour2 in 1 CARTONTABLET215
70000-0160-1Allergy Relief4 Hour12 in 1 BLISTER PACKTABLET1215
70000-0160-2Allergy Relief4 Hour1 in 1 CARTONTABLET115
70000-0160-2Allergy Relief4 Hour100 in 1 BOTTLETABLET10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0160-1EA - Each70000-016013e95c3a-e091-44ed-8a21-3b7a4b27881612018-12-13
70000-0160-2EA - Each70000-0160625564fe-e437-4949-b458-c6ddb9e5e05b12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0160ALLERGY RELIEF 4 HOUR (CHLORPHENIRAMINE MALEATE) TABLET [CARDINAL HEALTH 110, LLC. DBA LEADER]13Current NDC, Legacy NDC, 4 package rows20240702_aaecfda5-1a50-4d8a-9909-7153c1a22bda.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 87 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GANMAOLINGACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.c757a03e-59ea-469c-970d-4bc62e73f36f2025-11-18WarningsExact identifier
application number: M012
M-DrylDIPHENHYDRAMINE HYDROCHLORIDEBryant Ranch Prepacke1d545dc-9222-4d61-964d-1c781215d7d22025-11-18WarningsExact identifier
application number: M012
Goodnow cold flu day relief cold flu night reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGobrands, Inc7590d0c6-121e-4016-b6bb-534c5d0a79702025-11-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDER J General Corporationd786ae07-ce57-44c7-9ba5-f4c87df115de2025-11-17WarningsExact identifier
application number: M012
Benadryl AllergyDIPHENHYDRAMINE HYDROCHLORIDER J General Corporationc46c01c0-29f4-400c-bef5-14b3eb944c512025-11-17WarningsExact identifier
application number: M012
TYLENOL COLD AND FLUACETAMINPHENR J General Corporationb618877b-9dbc-4ba2-be2c-bf1922c646cc2025-11-17WarningsExact identifier
application number: M012
TYLENOL SINUS SEVEREACETAMINOPHENR J General Corporation2cbf7954-b28f-4d7b-b142-6c6c5c58b25d2025-11-17WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRR J General Corporation8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc2025-11-17WarningsExact identifier
application number: M012
Quality Choice Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILQUALITY CHOICE (Chain Drug Marketing Association)c0e3c959-bed6-2ce5-e053-2995a90a0be92025-11-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESINGeri-Care Pharmaceuticals, Corpc5ea5a7a-c806-e5e0-e053-2995a90a15e92025-11-17WarningsExact identifier
application number: M012
Multi-Symptom Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED50f3157b-5788-4b63-835a-e60c8dc33df92025-11-17WarningsExact identifier
application number: M012
Day and Night SinusACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores Inca9d809f5-63a1-4f80-8b4d-33e8e052c7bd2025-11-15WarningsExact identifier
application number: M012
Cold and Flu Day, NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Company937b481a-e0b7-4d34-a8a1-0bfb2b867c2b2025-11-15WarningsExact identifier
application number: M012
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.f701a6ae-200d-48dc-94e4-6bd3228f50d42025-11-15WarningsExact identifier
application number: M012
MULTI-SYMPTOM COLDDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb1fae7cc-4033-44bc-aa7c-ca3ceea51c7d2025-11-15WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation1affbef6-dd27-40c2-a5d3-b121aa62496a2025-11-15WarningsExact identifier
application number: M012
Cold and Flu Day, NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Companyb9adfb5d-6576-4ff8-a7d7-a89b867c52922025-11-14WarningsExact identifier
application number: M012
PECGEN DMXDEXTROMETHORPHAN HBR, GUAIFENESINKRAMER NOVISa627824c-5e3d-4672-a047-6c801b50b4322025-11-14WarningsExact identifier
application number: M012
Supress DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINKRAMER NOVIS7da0611e-729c-4cf8-88f3-f8877b9f5cfa2025-11-14WarningsExact identifier
application number: M012
G-ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Novisc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc2025-11-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSNaaecfda5-1a50-4d8a-9909-7153c1a22bda15
1363309chlorpheniramine maleate 4 MG Oral TabletSCDaaecfda5-1a50-4d8a-9909-7153c1a22bda15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0160-1700000160012 BLISTER PACK in 1 CARTON (70000-0160-1) > 12 TABLET in 1 BLISTER PACK2 blister pack1992-12-190000-00-00NoNoCurrent
70000-0160-2700000160021 BOTTLE in 1 CARTON (70000-0160-2) / 100 TABLET in 1 BOTTLE1 bottle1992-12-190000-00-00NoNoCurrent