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Chlo Hist Chlophedianol Hydrochloride, Dexbrompheniramine Maleate 12.5 mg/5mL; 1 mg/5mL Liquid, 473 mL — NDC 12830-0864-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Chlo Hist Chlophedianol Hydrochloride, Dexbrompheniramine Maleate 12.5 mg/5mL; 1 mg/5mL Liquid, 473 mL — NDC 12830-864-16 (Billing 12830-0864-16)

by R. A. McNeil Company · 473 mL in 1 BOTTLE

This is a package of 473 mL of Chlo Hist Chlophedianol Hydrochloride, Dexbrompheniramine Maleate 12.5 mg/5mL; 1 mg/5mL Liquid from R. A. McNeil Company, marketed since Sep 2014 and currently FDA-listed.

NDC 12830-0864-16
🏷️ FDA NDC (as labeled) 12830-864-16 billing pads the product segment with a zero
This package
Contains473 mL Pack sizes3 compare ↓
Product page 12830-0864-04 Also comes in: 20 ml 12830-864-20 120 ml 12830-864-04
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

NDC database record

One package, one record: these facts belong to NDC 12830-864-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
12830 labeler · 864 product · 16 package
Package marketed since
Sep 15, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
473 mL per package
Barcode (UPC)
0312830864166
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 12830-864-16
Product NDC 12830-864
11-digit billing NDC 12830086416
NCPDP billing unit ML — per mL (volume)
RxCUI 1551286
UNII 69QQ58998Y, BPA9UT29BS
UPC 0312830864166
Application # M012
SPL Set ID d046f4ba-5753-4ed5-a924-0b66fd116781
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-09-15
Route ORAL
Dosage form LIQUID
Substance CHLOPHEDIANOL HYDROCHLORIDE; DEXBROMPHENIRAMINE MALEATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43995702432020
GPI class Chlo Hist
GCN Seq No 072922
GCN 37178
HICL code 041451
Ingredient (HICL) Dexbrompheniramn/Chlophedianol
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4E
Therapeutic class — specific (HIC3) Non-Opioid Antitussive-1St Gen Antihistamine Comb.
AHFS code 04:04.20.00
AHFS class Propylamine Derivatives
FDB label name CHLO HIST ORAL SOLUTION
FDB brand name Chlo Hist
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 072922
  • GCN: 37178
  • GPI-14 (Medi-Span): 43995702432020
  • HICL (First Databank): 041451
  • AHFS class code: 04:04.20.00
  • RxCUI (RxNorm): 1551286
Why two NDCs? The FDA registers this code as 12830-864-16 — 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 → 12830-0864-16. 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 Other cough suppressants class.

Drug family (ATC) Other cough suppressants
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.

Clinical

Label name CHLO HIST ORAL SOLUTION Ingredient Dexbrompheniramn/Chlophedianol
🧪 What is this product?

Chlo Hist is an oral liquid cough and cold product sold over the counter under FDA's OTC monograph rules. It contains chlophedianol hydrochloride, a cough suppressant typically used to help reduce cough, and dexbrompheniramine maleate, an antihistamine commonly used to help relieve allergy and cold symptoms such as sneezing, runny nose, and itching. This product is meant for oral use and is marketed without individual FDA approval as a monograph drug.

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.

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 20 ml 120 ml
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
12830-0864-04 12830-864-04 Main listing 120 mL in 1 BOTTLE 2017-10-20 — Active
12830-0864-16 You're viewing this 473 mL in 1 BOTTLE 2014-09-15 — Active
12830-0864-20 12830-864-20 20 mL in 1 BOTTLE 2014-09-15 — Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 473 mL — 473 ml in 1 bottle.
How does this package differ from NDC 12830-0864-20?
Both are Chlo Hist Chlophedianol Hydrochloride, Dexbrompheniramine Maleate 12.5 mg/5mL; 1 mg/5mL Liquid — the drug itself is identical. This page's package is the 473 mL one, while NDC 12830-0864-20 is the 20 ml package.
What NDC number is used to bill for this package of Chlo Hist Chlophedianol Hydrochloride, Dexbrompheniramine Maleate 12.5 mg/5mL; 1 mg/5mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Chlo Hist 12.5 mg/5mL; 1 mg/5mLthis 12830-0864-16 R. 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

🏛️
2014
On the market since
Sep 2014
📍
2026
Currently FDA-listed
12 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.

What it looks like

FlavorGrape
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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.

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

The official label also statesitric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.

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.

Manufacturer & labeler

LabelerR. A. McNeil Company
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code12830
First marketedSep 2014
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from R. A. McNeil Company labeler code 12830

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.

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 32 words ▾

Uses A nonnaracotic cough suppressant and antihistamine for the temporary relief of: cough due to minor throat and bronchial irritation runny nose sneezing itching of the nose or throat itchy, watery eyes

⏱️ Dosage and Administration 62 words ▾

Directions Do not exceed recommended dosage. Adults and children 12 years of age and over: 2 teaspoonfuls (10 mL) every 6 hours, not to exceed 4 doses in 24 hours Children 6 to under 12 years of age: 1 teaspoonful (5 mL) every 6 hours, not to exceed 4 doses in 24 hours Children under 6 years of age: Consult a Physician.

⚠️ Warnings ~1 min read ▾

Warnings Do not exceed recommended dosage. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product.

Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when diving a motor vehicle or operating machinery. Ask a doctor before use if you have a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizes may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 13 words ▾

Other information Each 5 mL contains: Sodium 2 mg Store at 59°-86°F (15°-30°C)

🧪 Active Ingredient 21 words ▾

Drug Facts Active ingredients (in each 5 mL teaspoonful) Chlophedianol Hydrochloride 12.5 mg Dexbrompheniramine Maleate 1 mg Purpose Cough Suppressant Antihistamine

🧪 Inactive Ingredients 18 words ▾

Inactive ingredients itric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.

🎯 Purpose 4 words ▾

Purpose Cough Suppressant Antihistamine

📄 Ask a Doctor Before Use If 50 words ▾

Ask a doctor before use if you have a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

📄 When Using This Product 36 words ▾

When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizes may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 44 words ▾

Stop use and ask a doctor if cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 24 words ▾

Questions? Comments? Serious side effects associated with use of this product may be reported to this number. Call 1-423-493-9170 (8 a.m. to 5 p.m.)

📄 Package Label / Principal Display Panel 105 words ▾

Product Package Label for 473 mL NDC 12830-864-16 Chlo HIst Oral Solution Cough Suppressant Antihistamine Grape Flavor EACH 5 mL (1 TEASPOONFUL) CONTAINS: Chophedianol Hydrochloride..................................12.5 mg Dexbrompheniramine Maleate................................................1 mg Alcohol Free/Gluten Free Sugar Free/Dye Free ONE PINT (473 mL) Mfg. for R.A. McNeil Company Chattanooga, TN 37406-3738 Rev. 09/17 Tamper evident by foil seal under cap.

Do not use if foil seal is broken or missing. Dispense in a tight, light-resistant container with a child-resistant cap. THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

Manufactured for: R.A. McNeil Company 1150 Latta Street Chattanooga, TN 37406-3738 US Patent # 9,050,289 Rev. 09/17 label back

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

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 ✓ Available
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) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by R. A. McNeil Company. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 20 ml (12830-0864-20), 120 ml (12830-0864-04). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
R. A. McNeil Company 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.
← 12830-0816-16 · R. 12836-0304-01 · Ercros →
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.