FDA.reportPublic FDA data

Chlorpheniramine Maleate 4 mg

Product NDC
71335-0963
11-digit product format
713350963
Labeler code
71335
Product ID
71335-0963_e33c825b-bb98-458b-b725-95684ffe9f8a
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
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
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
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0963-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0963-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0963-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0963-4834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0963-5834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0963-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0963-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0963-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0963-41332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0963-51332a3947898…d4bfe170f9cd…

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
Chlorpheniramine Maleate 4 mg
Listing expiration
2026-12-31

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
54681242-c861-4415-b5c0-d3ab55b62be1Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-0963-12024-05-17Chlorpheniramine Maleate 4 mg
71335-0963-22024-05-17Chlorpheniramine Maleate 4 mg
71335-0963-32024-05-17Chlorpheniramine Maleate 4 mg
71335-0963-42024-05-17Chlorpheniramine Maleate 4 mg
71335-0963-52024-05-17Chlorpheniramine Maleate 4 mg
71335-0963-12024-01-30Chlorpheniramine Maleate 4 mg
71335-0963-22024-01-30Chlorpheniramine Maleate 4 mg
71335-0963-32024-01-30Chlorpheniramine Maleate 4 mg
71335-0963-42024-01-30Chlorpheniramine Maleate 4 mg
71335-0963-52024-01-30Chlorpheniramine Maleate 4 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0963-1Chlorpheniramine Maleate 4 mg30 in 1 BOTTLETABLET308
71335-0963-2Chlorpheniramine Maleate 4 mg60 in 1 BOTTLETABLET608
71335-0963-3Chlorpheniramine Maleate 4 mg100 in 1 BOTTLETABLET1008
71335-0963-4Chlorpheniramine Maleate 4 mg120 in 1 BOTTLETABLET1208
71335-0963-5Chlorpheniramine Maleate 4 mg40 in 1 BOTTLETABLET408
71335-0963-6Chlorpheniramine Maleate 4 mg24 in 1 BOTTLETABLET248

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0963CHLORPHENIRAMINE MALEATE 4 MG (CHLORPHENIRAMINE MALEATE) TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 6 package rows20240518_54681242-c861-4415-b5c0-d3ab55b62be1.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 2 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
application number: M012
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
application number: M012
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
application number: M012
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
application number: M012
Mucus Relief DM Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINRARITAN PHARMACEUTICALS INC4898b1c2-55ef-4589-982b-2279c01707e52026-09-08WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association, Inc.2a7afe03-3c34-4e30-827e-b3bb2568cb972026-09-08WarningsExact identifier
application number: M012
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDERite Aid Corporation71845bf9-8981-4ca0-a62c-dbef102b1b022026-09-04WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
application number: M012
NostrillaOXYMETAZOLINE HYDROCHLORIDEInsight Pharmaceuticals LLC86217847-8e2b-48cc-b289-4987fd3aa7c32026-09-04WarningsExact identifier
application number: M012
tussin cough chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation86fc3723-5fc5-4de5-bd04-7774c2abe5392026-09-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLCed576bf1-3949-423e-af2e-e4b1a3839b212026-09-04WarningsExact identifier
application number: M012
tussin nighttime coughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporation80d51af8-3a7b-4d22-8d4f-df5f919130472026-09-04WarningsExact identifier
application number: M012
NO MORE NOSEBLEEDOXYMETAZOLINE HYDROCHLORIDEDR. FRIEDMAN'S NO MORE NOSEBLEED KIT INC.69d3f1fe-b476-4f84-8c5e-94957b74b46c2026-09-04WarningsExact identifier
application number: M012
Ultra Fine Mist Sinus ReliefOXYMETAZOLINE HYDROCHLORIDEDOLGENCORP, INC.5f134840-2465-4585-a85d-08d746f76f7a2026-09-03WarningsExact identifier
application number: M012
Daytime Nighttime Severe Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCI DOXYLAMINE SUCINATEFamily Dollar (FAMILY WELLNESS)22918db6-9096-4eb8-a742-aaa2dd5c31da2026-09-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN54681242-c861-4415-b5c0-d3ab55b62be18
1363309chlorpheniramine maleate 4 MG Oral TabletSCD54681242-c861-4415-b5c0-d3ab55b62be18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0963-17133509630130 TABLET in 1 BOTTLE (71335-0963-1) 30 tablet2018-10-050000-00-00NoNoCurrent
71335-0963-27133509630260 TABLET in 1 BOTTLE (71335-0963-2) 60 tablet2024-05-170000-00-00NoNoCurrent
71335-0963-371335096303100 TABLET in 1 BOTTLE (71335-0963-3) 100 tablet2024-05-170000-00-00NoNoCurrent
71335-0963-471335096304120 TABLET in 1 BOTTLE (71335-0963-4) 120 tablet2024-05-170000-00-00NoNoCurrent
71335-0963-57133509630540 TABLET in 1 BOTTLE (71335-0963-5) 40 tablet2024-05-170000-00-00NoNoCurrent
71335-0963-67133509630624 TABLET in 1 BOTTLE (71335-0963-6) 24 tablet2024-05-17NoNoCurrent