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LoHist DM Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 10 mg/5mL; 5 mg/5mL; 2 mg/5mL Liquid, 473 mL — NDC 68047-0129-16 package photo

LoHist DM Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 10 mg/5mL; 5 mg/5mL; 2 mg/5mL Liquid, 473 mL

by Larken Laboratories, Inc. · 473 mL in 1 BOTTLE (68047-129-16)
NDC 68047-0129-16
🏷️ FDA NDC (as labeled) 68047-129-16 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 68047-129-16
Product NDC 68047-129
11-digit billing NDC 68047012916
NCPDP billing unit ML — per mL (volume)
RxCUI 1423702
UNII 9D2RTI9KYH, 04JA59TNSJ, IXA7C9ZN03
UPC 0368047129161
Application # M012
SPL Set ID 29730dab-fa09-4351-9b36-0359ba4f7744
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-06-01
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; BROMPHENIRAMINE MALEATE
GPI-14 43995803081220
GPI class LoHist-DM
GCN Seq No 050001
GCN 15847
HICL code 035368
Ingredient (HICL) Brompheniram/Phenylephrine/Dm
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3R
Therapeutic class — specific (HIC3) Non-Opioid Antitus-1St Gen.antihistamine-Decongest
AHFS code 04:04.20.00
AHFS class Propylamine Derivatives
FDB label name LOHIST-DM SYRUP
FDB brand name Lohist-Dm
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 68047-129-16 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68047-0129-16. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Substituted alkylamines class.

Drug family (ATC) Substituted alkylamines
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLarken Laboratories, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code68047
First marketedJun 2012
Product typeHuman Otc Drug
Portfolio12 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LOHIST-DM SYRUP Ingredient Brompheniram/Phenylephrine/Dm
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Brompheniramine is used to treat allergy and cold symptoms: sneezing runny nose itching of the nose or throat red, itchy, watery eyes Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Read the full MedlinePlus article ↗
🧪 What is this product?

LoHist DM is an oral liquid cold and allergy product that contains three active ingredients. Brompheniramine maleate is an antihistamine typically used to relieve sneezing, itching, and runny nose. Dextromethorphan hydrobromide is a cough suppressant commonly found in over-the-counter cough medicines. Phenylephrine hydrochloride is a decongestant typically used to help shrink nasal passages and ease congestion. This product is marketed as an OTC monograph drug, meaning it follows FDA's established guidelines for this category of cold and allergy remedies.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color red
FlavorStrawberry
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.075 $35.29 / 473 ml
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Oct 2025 May 2026 Jun 2026 Aug 2026 $0.075 $0.070
▲ Up 6% over the last 5 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
LoHist DM 10 mg/5mL; 5 mg/5mL; 2 mg/5mLthis 68047-0129-16 Larken 473 ml $0.075 — Availability likely —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2012
On the market since
Jun 2012
📍
2026
Currently FDA-listed
14 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Brompheniramine Maleate, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride — the ingredient across all brands.

Top reported reactions

Cerebrovascular Accident123
Haemorrhagic Stroke31
Convulsion23
Drug Hypersensitivity16
Injury16
Hemiparesis15
Headache13

Age at onset

Infant1
Child2
Adolescent1
Adult2
Elderly3

Reporter sex

317 reports
Male · 42%
Female · 57%
Unknown · 0%

Serious outcomes

Disabling115
Hospitalization75
Death22
Life-threatening5
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 8 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68047-0129-16 You're viewing this 473 mL in 1 BOTTLE (68047-129-16) 2012-06-01 Active

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 58 words ▾

Uses Temporarily relieves these symptoms due to hay fever (allergic rhinitis): cough due to minor throat and bronchial irritation runny nose sneezing itchy, watery eyes itching of the nose or throat Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis. Temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 68 words ▾

Directions Do not exceed 6 doses in a 24-hour period Age Dose Adults and children over 12 years of age 2 teaspoonsful (10 mL) every 4 hours Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 hours Children under 6 years of age Ask your doctor Other Information store at 20°-25°C (68°-77°F) very low sodium, contains 1 mg sodium per teaspoonful (5 mL)

⚠️ Warnings 65 words ▾

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.

🧪 Active Ingredient 22 words ▾

Active ingredients (In each 5 mL teaspoonful) Brompheniramine Maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg

🧪 Inactive Ingredients 20 words ▾

Inactive Ingredients Benzoic acid, edetate disodium, FD&C Red #40, propylene glycol, purified water, saccharin sodium, sorbitol solution, and strawberry flavoring

🎯 Purpose 13 words ▾

Purpose Brompheniramine Maleate Antihistamine Dextromethorphan HBr Antitussive (cough suppressant) Phenylephrine HCl Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68047-0120-16 · Larken 68047-0143-16 · Larken →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.