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 100 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MGC Health Cough Drops Honey HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa17272-fd7f-9ab4-e063-6394a90a585f2025-09-25WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa2e438-2ff3-a2df-e063-6394a90ac7b52025-09-25WarningsExact identifier
application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANTGUAIFENESINQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)63dad603-fe2f-42a6-a626-5c8048a42c102025-09-25WarningsExact identifier
application number: M012
Giltuss Childrens Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa5220f-38bb-9ef6-e063-6294a90aeff82025-09-25WarningsExact identifier
application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHealth Pharma USA LLCa03befb4-d86d-43e4-8097-eda5c8bb25be2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f8d7d47-f14c-888c-e063-6394a90a5cdd2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3f909bc2-eb84-a19d-e063-6294a90ae04e2025-09-24WarningsExact identifier
application number: M012
Giltuss Honey DM CoughDEXTROMETHORPHAN HBRDextrum Laboratories, Inc3f79137f-f0b0-d22c-e063-6394a90a72452025-09-23WarningsExact identifier
application number: M012
GoodSense Medicated Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLGOOD SENSE240bb6af-9d38-49fe-9011-3016246b09862025-09-23WarningsExact identifier
application number: M012
Xpect Honey Lemon Cough DropsHONEY LEMON COUGH DROPSCintas Corporation79e0b7c1-4acc-41d2-89cd-d075a8bac0c92025-09-23WarningsExact identifier
application number: M012
Topcare NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCb2b3c450-e988-41d1-9e53-cc8e30d75cb42025-09-23WarningsExact identifier
application number: M012
Xpect Cherry Cough DropsCHERRY COUGH DROPSCintas Corporationd1fd2f23-5435-405d-a7fd-644691f79e802025-09-23WarningsExact identifier
application number: M012
Topcare DayTime NiteTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLC560fb22b-391f-4d7b-a6fd-38d577d404b02025-09-23WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f67ac3d-1503-3418-e063-6394a90a938f2025-09-22WarningsExact identifier
application number: M012
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories Inc.3f68e68a-cf32-9df8-e063-6394a90a30122025-09-22WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKramer Novisf0bec5f5-4d76-471e-9024-557eba848b932025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.9f050fb0-6100-4b14-b82f-1d5fcbf165402025-09-22WarningsExact identifier
application number: M012
RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrive Pharmaceuticals Inc.c6392ace-c7d1-4450-8b71-4dccc60b4f022025-09-22WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3f12ee8f-d1c6-d73a-e063-6394a90a91992025-09-18WarningsExact identifier
application number: M012
Giltuss DGILTUSS DDextrum Laboratories Inc.3f17eefb-b625-b0f2-e063-6294a90afd4d2025-09-18WarningsExact 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