Aller-chlor

Product NDC
0536-1006
11-digit product format
005361006
Labeler code
0536
Product ID
0536-1006_7457e524-40ab-432f-a48a-b32eb2c0a93f
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Rugby Laboratories
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 packagepackage0536-10060536-1006-35DDiscontinued by firm2026-10-23

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
Aller-chlor
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1363309Internal RxNorm lookup
1363315Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
04ca3806-72be-47d4-9fea-5b0dee087683Available 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
0536-1006-01Aller-chlor100 in 1 BOTTLE, PLASTICTABLET10016
0536-1006-01Aller-chlor1 in 1 CARTONTABLET116
0536-1006-10Aller-chlor1000 in 1 BOTTLE, PLASTICTABLET100016
0536-1006-35Aller-chlor12 in 1 BLISTER PACKTABLET1216
0536-1006-35Aller-chlor2 in 1 CARTONTABLET216

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1006-01EA - Each0536-1006270e3d12-6807-4d73-a4ac-8095b9e4ddd112015-01-05
0536-1006-10EA - Each0536-1006408f78fc-0a2b-4ee6-bf90-2376920c842712014-10-03
0536-1006-35EA - Each0536-100612500282-7eed-43ac-ae9d-c106fee7987812014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]4
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1006ALLER-CHLOR (CHLORPHENIRAMINE MALEATE) TABLET [RUGBY LABORATORIES]15Current NDC, Legacy NDC, 5 package rows20250512_04ca3806-72be-47d4-9fea-5b0dee087683.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 24 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Runny Nose Childrens PlusACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDETOP CARE (Topco Associates LLC)6f04bd51-093c-4624-aef3-0145ac3873862026-06-01WarningsExact identifier
application number: M012
NasalPHENYLEPHRINE HYDROCHLORIDECVS Pharmacy694a3116-1b75-42cd-bbcf-d19831c2d7962026-06-01WarningsExact identifier
application number: M012
night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH E Bcf31538c-9eee-4c81-80cb-66eecabf0aff2026-06-01WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC155e07b3-0a08-3be8-e063-6394a90a76352026-05-31WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough NighttimeDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC156033ae-b16a-007b-e063-6294a90a74452026-05-31WarningsExact identifier
application number: M012
Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyebf8c82d-a653-4c02-893b-61704901acbb2026-05-29WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLAmerisource Bergen934c7b91-3cba-47f0-8efa-77216f3f15c42026-05-29WarningsExact identifier
application number: M012
Allergy MedicineDIPHENHYDRAMINE HCLCOSTCO WHOLESALE CORPORATIONd9f03e11-d11f-43ee-8ed0-9e07d1058f662026-05-29WarningsExact identifier
application number: M012
Cold Childrens, Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYeaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d2026-05-29WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC3598ac5b-29f9-f002-e063-6294a90a62cb2026-05-28WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC51badd2f-4a43-3dbe-e063-6294a90a4bd12026-05-28WarningsExact identifier
application number: M012
Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.a7ab2140-de09-158f-e053-2a95a90a25a02026-05-28WarningsExact identifier
application number: M012
Kids Multi Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.2d918ec8-3098-1d09-e063-6294a90a9e8f2026-05-28WarningsExact identifier
application number: M012
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLGenexa Inc.213fe898-dace-9a0f-e063-6394a90afd642026-05-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey Lemon FlavorMENTHOLMedical Group Care LLC556628ab-e233-92fe-e063-6394a90a00902026-05-28WarningsExact identifier
application number: M012
Sinus Decongestion PEPHENYLEPHRINE HCLKroger Company68eff734-177e-4999-9126-6b92bb2041072026-05-28WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRARMY AND AIR FORCE EXCHANGE SERVICEff39084f-ab2f-48ed-ac62-837f7fff2b652026-05-28WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo PackDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC16637d54-8049-d3ce-e063-6394a90aafc92026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN7a3452a2-930f-48b1-8c59-dbceb10b9c7818
1363309chlorpheniramine maleate 4 MG Oral TabletSCD7a3452a2-930f-48b1-8c59-dbceb10b9c7818
1363315Aller-Chlor 4 MG Oral TabletPSN04ca3806-72be-47d4-9fea-5b0dee08768316
1363309chlorpheniramine maleate 4 MG Oral TabletPSN04ca3806-72be-47d4-9fea-5b0dee08768316
1363315chlorpheniramine maleate 4 MG Oral Tablet [Aller-Chlor]SBD04ca3806-72be-47d4-9fea-5b0dee08768316
1363309chlorpheniramine maleate 4 MG Oral TabletSCD04ca3806-72be-47d4-9fea-5b0dee08768316
1363315Aller-Chlor 4 MG Oral TabletSY04ca3806-72be-47d4-9fea-5b0dee08768316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1006-01005361006011 BOTTLE, PLASTIC in 1 CARTON (0536-1006-01) / 100 TABLET in 1 BOTTLE, PLASTIC1992-12-192027-01-31NoNoCurrent
0536-1006-10005361006101000 TABLET in 1 BOTTLE, PLASTIC (0536-1006-10) 1000 tablet1992-12-190000-00-00NoNoCurrent
0536-1006-350053610063512 in 1 BLISTER PACKHistorical