FDA.reportPublic FDA data

SPRINSOL

Product NDC
51467-101
11-digit product format
514670101
Labeler code
51467
Product ID
51467-101_5bb2539e-7b84-8b52-e063-6294a90a9635
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine maleate
Dosage form
TABLET
Route
ORAL
Labeler
FORTUNE PHARMACAL COMPANY LIMITED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-01
Marketing end
2029-06-30
Substance
CHLORPHENIRAMINE MALEATE
Active strength
4 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

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
SPRINSOL

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1

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
51467-101-01SPRINSOL2 in 1 BOXTABLET23
51467-101-01SPRINSOL12 in 1 BLISTER PACKTABLET123
51467-101-02SPRINSOL3 in 1 BOXTABLET33
51467-101-02SPRINSOL12 in 1 BLISTER PACKTABLET123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51467-101SPRINSOL (CHLORPHENIRAMINE MALEATE) TABLET [FORTUNE PHARMACAL COMPANY LIMITED]2Current NDC, Legacy NDC, 4 package rows20241121_01a1a91e-04ba-4526-8946-10483932b30c.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 52 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus and Headache DaytimeACETAMINOPHEN, PHENYLEPHRINE HCLDOLGENCORP, LLC869e950c-5861-4840-aaad-b0342790d62b2026-02-10WarningsExact identifier
application number: M012
CareOne Night TIme Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyd6b9fb27-3ef7-47ee-81f2-b9a3ccd6de252026-02-10WarningsExact identifier
application number: M012
Medique Cold Cough ProductACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL ,Sportpharm LLCd61df3a4-8ae2-46b1-b322-7f4e04cc1bf92026-02-09WarningsExact identifier
application number: M012
Sinus Congestion and Pain DaytimeACETAMINOPHEN AND PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIf3fc270a-92fc-46d5-b187-44e875c3abb92026-02-09WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.d5c8b248-6d82-4eac-881c-0b9d0a0de8f12026-02-09WarningsExact identifier
application number: M012
DayTime/NiteTime Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incd07112dd-27df-46cc-b7c3-af8ba7601d062026-02-09WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEKenvue Brands LLC48f7933e-6582-638c-e063-6394a90abfe52026-02-06WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLRetail Business Services, LLC4fb46860-2bf9-41a7-89eb-31c259c611072026-02-06Warnings, Adverse reactionsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLSportpharm LLC909dacfa-50d3-4bcf-b2df-5405427cfaad2026-02-06WarningsExact identifier
application number: M012
Good Sense NasalOXYMETAZOLINE HYDROCHLORIDESportpharm LLCf91b7c1f-e074-4767-b9c8-dbf1937a6a0f2026-02-06WarningsExact identifier
application number: M012
Severe Allergy And Sinus Headache Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacyb3c744b8-aa93-505d-f8cf-07995da4283d2026-02-06WarningsExact identifier
application number: M012
NightTime Cold and Flu Multi SymptomACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATEWinCo Foods, LLC911e6a51-c0f0-491a-b70c-00011ed5e35b2026-02-06WarningsExact identifier
application number: M012
Severe Sinus Daytime, Non-DrowsyACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycc0dc951-5024-4517-9d38-a01699407e7e2026-02-06WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLPharmacy Value Alliance, LLCd836c3e2-3b69-41f3-b166-21270550e8ab2026-02-05Warnings, Adverse reactionsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLPublix Super Markets, Inc.81b1d5bb-f813-4f79-9559-2494db33ad3c2026-02-05Warnings, Adverse reactionsExact identifier
application number: M012
NasalOXYMETAZOLINE HYDROCHLORIDEKroger Company6499f854-2995-48cb-9c80-be6524b3db432026-02-05WarningsExact identifier
application number: M012
Cold and Flu plus Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.52a398eb-e593-458b-9c42-6f653ca391be2026-02-04WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLHy-Vee, Inc.446de381-6685-748d-e063-6394a90a1b732026-02-04Warnings, Adverse reactionsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED85aadc86-d979-41a1-849a-e2ccc90144292026-02-04WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Incfa8c154c-56c6-47de-8e43-9e012b4be95f2026-02-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN01a1a91e-04ba-4526-8946-10483932b30c3
1363309chlorpheniramine maleate 4 MG Oral TabletSCD01a1a91e-04ba-4526-8946-10483932b30c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51467-101-01514670101012 BLISTER PACK in 1 BOX (51467-101-01) / 12 TABLET in 1 BLISTER PACK2 blister pack2025-07-012029-06-30NoNoCurrent
51467-101-02514670101023 BLISTER PACK in 1 BOX (51467-101-02) / 12 TABLET in 1 BLISTER PACK3 blister pack2025-07-012029-06-30NoNoCurrent