FDA.reportPublic FDA data

LoHist

Product NDC
68047-120
11-digit product format
680470120
Labeler code
68047
Product ID
68047-120_413948dd-d2dc-dac0-e063-6394a90a4db9
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
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LoHist
Brand name suffix
D
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z, 6V9V2RYJ8N
Rxcui1053618

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

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 ml2003-09-150000-00-00NoNoCurrent