FDA.reportPublic FDA data

SPRINSOL

Product NDC
51467-101
Requested package NDC
51467-101-01
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 138 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
careone tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINAmerican Sales Company6c90fccf-0e6f-43df-9468-d8ece8ded0092024-11-11WarningsExact identifier
application number: M012
good sense night time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company89dc1423-d097-47a8-9025-eab5381cca262024-11-11WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC10f9627b-edda-422a-b01f-7066f9c983352024-11-11WarningsExact identifier
application number: M012
nighttime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED17c3fe42-3c40-4405-80b7-b3f9e4aa83762024-11-11WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B1dd36aa7-f085-4350-8cf2-f9fa29b583e42024-11-11WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCa7f9f1d0-7498-461c-b4e8-4c92cf3feae82024-11-11WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalgreen Companybd079f5d-0a38-40e6-9661-e8236c88a24d2024-11-11WarningsExact identifier
application number: M012
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANPAI Holdings, LLC dba PAI Pharmaff970fff-d1a3-4322-83b4-34e361431a1c2024-11-11WarningsExact identifier
application number: M012
topcare tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETopco Associates LLCe1118592-30ac-4505-9f38-c6d395c4cf5b2024-11-11WarningsExact identifier
application number: M012
basic care nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC624b8029-9fdb-4908-a13b-f9dd750301202024-11-11WarningsExact identifier
application number: M012
Biofreeze ColorlessMENTHOLA-S Medication Solutionscc1cba14-da40-4d7d-b522-b5c648798e962024-11-11WarningsExact identifier
application number: M012
foster and thrive nighttime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLC298b7754-d0d8-496d-9949-4c346cb11e342024-11-11WarningsExact identifier
application number: M012
leader tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leaderb418c10c-528b-4395-944e-af959b639ec22024-11-10WarningsExact identifier
application number: M012
equaline adult tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINUnited Natural Foods, Inc. dba UNFIf7c753f8-4b12-4797-a599-736d597bc1bc2024-11-10WarningsExact identifier
application number: M012
foster and thrive adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINStrategic Sourcing Services LLCf8933226-fbc9-44e3-a90f-4e6c1dbdb7b72024-11-10WarningsExact identifier
application number: M012
dg health adult tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc81f12484-ddf7-49c6-b530-3a81d62ab40d2024-11-10WarningsExact identifier
application number: M012
careone tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRetail Business Services, LLC230fa1ea-ae7c-425e-8447-79a90c96ae9e2024-11-10WarningsExact identifier
application number: M012
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Companycb8a1d81-b1a3-4217-b157-9e5d398f202d2024-11-09WarningsExact identifier
application number: M012
PhysiciansCare Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEAcme United Corporation5e31b1ff-291f-7b8c-e053-2a91aa0aedbc2024-11-09WarningsExact identifier
application number: M012
DurafluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.55fffc1d-8449-4c28-a391-c6f60dd856222024-11-09WarningsExact 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