Home NDC 68047-129 LoHist DM
Product NDC 68047-129
11-digit product format 680470129
Labeler code 68047
Product ID 68047-129_413a398f-3a46-e230-e063-6294a90af21a
Type HUMAN OTC DRUG
Nonproprietary name Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Larken Laboratories, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-06-01
Substance BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 2; 10; 5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LoHist DM BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE Larken Laboratories, Inc. 29730dab-fa09-4351-9b36-0359ba4f7744 2025-10-15 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Do not use to sedate a child or make a child sleepy if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this drug.
Additional Listing Data#
Finished product Yes
Brand name base LoHist DM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 2 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL BROMPHENIRAMINE MALEATE 5 mg/5mL
Harmonized Identifiers# Field, Values table Field Values Unii 9D2RTI9KYH, 04JA59TNSJ, IXA7C9ZN03 Rxcui 1423702
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68047-129-16 LoHist DM 473 mL in 1 BOTTLE LIQUID 473 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BROMPHENIRAMINE MALEATE ACTIVE INGREDIENT IXA7C9ZN03 LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 BROMPHENIRAMINE ACTIVE MOIETY H57G17P2FN LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 SACCHARIN SODIUM DIHYDRATE INACTIVE INGREDIENT SB8ZUX40TY LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68047-129 LOHIST DM (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [LARKEN LABORATORIES, INC.] 11 Current NDC, Legacy NDC, 1 package rows 20241013_29730dab-fa09-4351-9b36-0359ba4f7744.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68047-129-16 68047012916 473 mL in 1 BOTTLE (68047-129-16) 473 ml 2012-06-01 0000-00-00 No No Current