FDA.reportPublic FDA data

LoHist

Product NDC
68047-120
11-digit product format
680470120
Labeler code
68047
Product ID
68047-120_56be316a-4767-3a8e-e063-6294a90a46c1
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate / Pseudoephedrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Larken Laboratories, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-09-15
Marketing end
2030-05-21
Substance
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
2; 30 mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [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
LoHist
Brand name suffix
D

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/5mL
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1053618Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
93c9ad4f-3376-48c2-8276-0375663acd01Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68047-120-16LoHistD473 mL in 1 BOTTLELIQUID47311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68047-120-16ML - Milliliter68047-120bade0cf9-7697-4f43-80bf-ae9cd5dd830c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZLOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.]2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NLOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.]2
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965ULOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FLOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.]2
SACCHARIN SODIUM ANHYDROUSINACTIVE INGREDIENTI4807BK602LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RLOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RLOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68047-120LOHIST D (CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL) LIQUID [LARKEN LABORATORIES, INC.]10Current NDC, Legacy NDC, 1 package rows20241012_93c9ad4f-3376-48c2-8276-0375663acd01.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 18 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus CongestionPHENYLEPHRINE HCLL.N.K. International, Inc.81f0276a-99a2-4a57-a0d8-224735aa8c792026-07-10WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN, PHENYLEPHRINE HCLRite Aid Corporationefaf3be1-ab39-45f7-a45c-7fea8705c8d02026-07-10WarningsExact identifier
application number: M012
Equate Daytime Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.f847d9f2-aa47-4bbe-8f06-19356c6373982026-07-10WarningsExact identifier
application number: M012
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLTopco Associates, LLC2a80fba9-5e30-4ec0-bd8e-8957c0654b6c2026-07-10WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50230cad-3d04-8882-e063-6294a90acf3c2026-07-09WarningsExact identifier
application number: M012
Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLRugby Laboratoriesfc42e97d-1224-4d29-a55d-1a1885e0bf8f2026-07-09WarningsExact identifier
application number: M012
Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader7418d92d-a540-40d6-91d0-b7eb1f87f8ff2026-07-08WarningsExact identifier
application number: M012
DG HEALTH COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d2026-07-08WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLTopco Associates, LLCbfcabe02-7961-4407-a748-8cd0877313982026-07-08WarningsExact identifier
application number: M012
Aller-chlorCHLORPHENIRAMINE MALEATERugby Laboratories04ca3806-72be-47d4-9fea-5b0dee0876832026-07-08WarningsExact identifier
application number: M012
nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED24c22c9f-0c2f-46dc-850e-ed05f00d3e952026-07-08WarningsExact identifier
application number: M012
NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.0e65c5d1-a18b-452c-9be6-8d44d34577e92026-07-08WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATECardinal Health 110, LLC. DBA Leaderaaecfda5-1a50-4d8a-9909-7153c1a22bda2026-07-08WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7cb9f378-5d64-475f-bf26-4058ba6c15b42026-07-08WarningsExact identifier
application number: M012
DG HEALTH DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Incf174d08e-3335-4cc9-8766-4070f18c4f312026-07-08WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESIN 400 MGHealth Pharma USA LLCd60a3e9d-e88e-3b19-e053-2995a90a3e8d2026-07-07WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLCd38f47ea-7fda-170b-e053-2995a90adc822026-07-07WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsExact identifier
application number: M012
Cold and Flu Severe Day Time / Night TimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCacdcc6ce-c190-4de6-b126-62fe9043112e2026-07-07WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC471b1a43-1708-8be7-e063-6394a90a9bb72026-07-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053618chlorpheniramine maleate 2 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN93c9ad4f-3376-48c2-8276-0375663acd0111
1053618chlorpheniramine maleate 0.4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD93c9ad4f-3376-48c2-8276-0375663acd0111
1053618chlorpheniramine maleate 2 MG / psuedoephedrine hydrochloride 30 MG per 5 ML SyrupSY93c9ad4f-3376-48c2-8276-0375663acd0111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68047-120-1668047012016473 mL in 1 BOTTLE (68047-120-16) 473 ml2003-09-152030-05-21NoNoCurrent