NDC 68047-0120-16 — LoHist D Chlorpheniramine Maleate /

🆔 Identity & classification

FDA NDC (as labeled) 68047-120-16

Product NDC 68047-120

11-digit billing NDC 68047012016

NCPDP billing unit ML — per mL (volume)

RxCUI 1053618

UNII V1Q0O9OJ9Z, 6V9V2RYJ8N

UPC 0368047120168

Application # M012

SPL Set ID 93c9ad4f-3376-48c2-8276-0375663acd01

Established class (EPC) Histamine-1 Receptor Antagonist; alpha-Adrenergic Agonist

Mechanism of action Adrenergic alpha-Agonists; Histamine H1 Receptor Antagonists

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2003-09-15

Marketing end 2030-05-21

Route ORAL

Dosage form LIQUID

Substance CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

GCN Seq No 024816

GCN 44021

HICL code 000503

Ingredient (HICL) Chlorpheniramine/Pseudoephed

HIC1 code Z

Therapeutic class — broad (HIC1) Body As A Whole

HIC2 code Z2

Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants

HIC3 code Z2N

Therapeutic class — specific (HIC3) 1St Gen Antihistamine And Decongestant Combination

AHFS code 04:04.00.00

AHFS class First Generation Antihistamines

FDB label name LOHIST-D LIQUID

FDB brand name Lohist-D

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 68047-120-16 — 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 → 68047-0120-16. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist

Drug family (ATC) Substituted alkylamines

How it works Histamine H1 Receptor Antagonists

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 marketedSep 2003

Product typeHuman Otc Drug

Portfolio12 products on file

🔎 All NDCs from Larken Laboratories, Inc.

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-D LIQUID Ingredient Chlorpheniramine/Pseudoephed

🧪 What is this product?

LoHist D is an over-the-counter liquid medication taken by mouth. It combines chlorpheniramine maleate, an antihistamine typically used to reduce allergy symptoms such as itching, sneezing, and runny nose, with pseudoephedrine hydrochloride, a decongestant commonly used to relieve nasal congestion. This product is marketed under FDA's established rules for over-the-counter cold and allergy medicines.

Patient education

📘 MedlinePlus patient leaflet ↗

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

FlavorCherry

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
UNII I4807BK602
Saccharin sodium anhydrous is an artificial sweetener derived from saccharin that contains no water. It's added to medicines to improve taste and make them easier to swallow, especially in liquid formulations and chewable tablets.
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescherry flavoring, methylparaben, polyethylene glycol, propylparaben, purified water saccharin sodium, and sorbitol

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$0.1110	$52.50 / 473 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
LoHist D 2 mg/5mL; 30 mg/5mLthis 68047-0120-16	Larken	473 ml	—	—	FDA listed	—
LoHist-D 2 mg/5mL; 30 mg/5mL 68047-0159-16	Larken	473 ml	—	—	FDA listed	—

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

🏛️

2003

On the market since

Sep 2003

📍

2026

Currently FDA-listed

23 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 68047-0120-16, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

2K

Units reimbursed last 4 qtrs

300.1K

Gross reimbursed last 4 qtrs

$33.3K

Avg / prescription

$16.66

Avg / unit

$0.1110

Latest quarter Q4 2025

813Rx

Fee-for-service vs managed care ⓘ

100% MCO

Fee-for-service · 0 Rx Managed care · 2,000 Rx

State Medicaid map

Units reimbursed · per 100k residents

14.86,462

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Louisiana 6,462 /100k

2 Texas 14.8 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
68047-0120-16 You're viewing this	473 mL in 1 BOTTLE (68047-120-16)	2003-09-15	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	✓ Available

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 68047-120-16, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68047-0120-16, written without dashes as 68047012016. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 68047-0120-16, the first segment (68047) is the labeler code FDA assigned to Larken Laboratories, Inc.; the middle segment (0120) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (16) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but Larken Laboratories, Inc. has reported a marketing end date of 2030-05-21, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.

Who lists this product with the FDA?

Larken Laboratories, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 46 words ▾

Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itching of the nose or throat itchy, watery eyes temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 55 words ▾

Directions Do not exceed 4 doses in a 24-hour period Age Dose Adults and children over 12 years of age 2 teaspoonfuls (10 mL) every 4 to 6 hours Children 6 to under 12 years of age 1 teaspoonful (5 mL) every 4 to 6 hours Children under 6 years of age Ask your doctor

⚠️ 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 17 words ▾

Active Ingredients (In each 5 mL teaspoonful) Chlorpheniramine Maleate, USP 2 mg Pseudoephedrine HCl, USP 30 mg

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients cherry flavoring, methylparaben, polyethylene glycol, propylparaben, purified water saccharin sodium, and sorbitol

🎯 Purpose 8 words ▾

Purpose Chlorpheniramine Maleate Antihistamine Pseudoephedrine HCl Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Chlorpheniramine Maleate / Pseudoephedrine Hcl NDCsSame ingredient 🏭 All Larken labeler NDCsLabeler code 68047 📚 All Histamine-1 Receptor Antagonist NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — 1St Gen Antihistamine And Decongestant Combination.

Phenylephrine Hcl/Prometh Hcl 00121-0926-16 Pseudoephed/Diphenhydramine 00363-0192-08 Chlorpheniramine/Phenylephrine 00363-0462-07 Brompheniramine/Phenylephrine 00485-0202-16 Brompheniramin/Pseudoephedrine 00485-0206-16 Phenylephrine Hcl/Pheniramine 50991-0776-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

LoHist D Chlorpheniramine Maleate / Pseudoephedrine HCl 2 mg/5mL; 30 mg/5mL Liquid, 473 mL

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class