Home › NDC Lookup › Ingredients › Menthol Herb › 51316-0850-01
Natural Herb Cough Drops Menthol 4.8 mg Pastille, 60-count — NDC 51316-0850-01 package photo

Natural Herb Cough Drops Menthol 4.8 mg Pastille, 60-count

by CVS Pharmacy · 60 PASTILLE in 1 BAG (51316-850-01)
NDC 51316-0850-01
🏷️ FDA NDC (as labeled) 51316-850-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 51316-850-01
Product NDC 51316-850
11-digit billing NDC 51316085001
RxCUI 637119
UNII L7T10EIP3A
UPC 0050428513729
Application # M012
SPL Set ID fcd16063-abca-49a0-e053-6294a90acb26
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-29
Route ORAL
Dosage form PASTILLE
Substance MENTHOL
Why two NDCs? The FDA registers this code as 51316-850-01 — 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 → 51316-0850-01. 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.

🏭 Manufacturer & labeler

LabelerCVS Pharmacy
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code51316
First marketedMay 2023
Product typeHuman Otc Drug
Portfolio550 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

📗 Our plain-language guide HelloPharmacist
  • Menthol is found in a lot of over-the-counter topical products — creams, gels, patches, sprays, and powders. Depending on the product, it's used to temporarily ease minor muscle an...
  • Start with clean, dry skin — free of lotions or creams — before applying the patch. Peel the backing off and press the sticky side firmly to the sore area. Most menthol patches sho...
  • Yes, a mild burning or tingling feeling right after applying a menthol product is common and usually settles down within a few days of regular use. What's not normal is severe burn...
  • Is that burning sensation after I apply it normal?
📖 Read our full Menthol guide →

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 brown
ShapeOval
ImprintNone
Size25 mm
FlavorMenthol
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 T9D99G2B1R
    Caramel is a brown coloring substance made by heating sugar. It's added to medicines to give them color and sometimes a slight sweet taste without affecting how the drug works.
  • UNII 9G5L16BK6N
    A thick, sweet liquid made from corn starch. It acts as a sweetener, thickener, and binder in medicines, helping create the right texture and taste while holding ingredients together.
  • UNII K08036XEJV
    Horehound is a plant extract used as a flavoring agent in medicines. It adds a distinctive bitter or minty taste to help mask unpleasant flavors in syrups and lozenges.
  • UNII X7HKN4FOJI
    A plant extract from hyssop flowers, traditionally used in herbal preparations. It may function as a flavoring agent, fragrance, or botanical extract to add therapeutic or sensory qualities to the medicine.
  • UNII 17H39B00T5
    A plant extract from common mallow leaves used as a natural flavoring agent and skin-conditioning ingredient in some formulations. It may help provide mild taste or texture qualities to the medicine.
  • UNII RCU5REA2I1
    Melissa officinalis flower, also called lemon balm flower, is a plant-derived ingredient used as a flavoring or fragrance agent in medicines. It may also serve as a natural colorant or botanical additive.
  • UNII V95R5KMY2B
    Peppermint is a flavoring agent derived from the peppermint plant. It's added to medicines to improve taste and mask bitter or unpleasant flavors, making them easier to take.
  • UNII 065C5D077J
    Sage is a natural plant extract used in medicines as a flavoring agent and preservative. It may help mask bitter tastes and extend shelf life in certain formulations.
  • UNII 07V4DX094T
    Sambucus nigra flower is an extract from the black elderflower plant. It may be added to medicines as a flavoring or coloring agent, or to provide traditional herbal characteristics to the formulation.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII CW657OBU4N
    A plant extract from thyme used as a flavoring agent and preservative in medicines. It adds taste and aroma while helping protect the product from spoilage.
  • UNII CFN6G1F6YK
    A plant extract from small-leaved linden flowers, used as a flavoring agent and natural coloring ingredient to improve taste and appearance in medicines.
  • UNII KXK6I80R8W
    Wild thyme is a plant extract used in medicines as a flavoring and aromatic agent. It may also provide mild antimicrobial or soothing properties to the formulation.

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

The official label also statescaramel color, blend of herb extracts (elderflower, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme. wild thyme) glucose syrup, natural flavors, sucrose

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 systemPer eachPer 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.
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
Natural Herbal Cough Drops 4.8 mg 11673-0144-01 Target 50 pastilles — — FDA listed —
HyVee Cough Drops Original Herb 4.8 mg 42507-0906-30 HY-VEE, 30 lozenges — — FDA listed —
Herbal Flavor Menthol Cough Drops 4.8 mg 42681-0039-01 WHOLE 45 pastilles — — FDA listed —
Natural Herb Cough Drops 4.8 mgthis 51316-0850-01 CVS 60 pastilles — — FDA listed —
The Original Natural Herb Cough Drops 4.8 mg 54305-0175-10 Ricola 10 lozenges — — FDA listed —
Mountain Herb Sugar Free With Stevia Cough Suppressant Oral Anesthetic 4.8 mg 54305-0185-19 Ricola 19 lozenges — — FDA listed —
Sugar Free Original Swiss Herb Cough Suppressant Throat Drops 4.8 mg 54305-0802-19 Ricola 19 lozenges — — FDA listed —
Exchange Select Cough Drops Original Herb 4.8 mg 55301-0587-30 Army 30 lozenges — — FDA listed —
Mountain Herb Sugar Free With Stevia Cough Suppressant Oral Anesthetic 4.8 mg 63667-0185-19 Ricola 19 lozenges — — FDA listed —
The Original Natural Herb Cough Drops 4.8 mg 63667-0955-10 Ricola 10 lozenges — — FDA listed —
Sugar Free Mountain Herb Cough Suppressant Throat Drops 4.8 mg 63667-0958-19 Ricola 19 lozenges — — FDA listed —
Natural Herbal Cough Drops 4.8 mg 72628-0107-01 BOSTON 50 pastilles — — FDA listed —
Natural Herbal Cough Drops 4.8 mg 72628-0111-01 BOSTON 50 pastilles — — FDA listed —
Herbal Cough Drops Original Herb 4.8 mg 76162-0061-01 Topco 45 pastilles — — FDA listed —
MGC Health Cough Drops Original Herb 4.8 mg 83173-0131-30 Medical 30 lozenges — — FDA listed —
MGC Health Cough Drops Original Herb 4.8 mg 83698-0131-30 Xiamen 30 lozenges — — FDA listed —
Exchange Select Cough Drops Original Herb 4.8 mg 83698-0585-30 Xiamen 30 lozenges — — FDA listed —
HyVee Cough Drops Original Herb 4.8 mg 83698-0906-30 Xiamen 30 lozenges — — FDA listed —
Vicks Herbal Drops 4.8 mg 84126-0323-50 The 50 lozenges — — 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

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51316-0850-01 You're viewing this 60 PASTILLE in 1 BAG (51316-850-01) 2023-05-29 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 ✓ 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 FDA registers it as 51316-850-01, 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: 51316-0850-01, written without dashes as 51316085001. 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 51316-0850-01, the first segment (51316) is the labeler code FDA assigned to CVS Pharmacy; the middle segment (0850) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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: this package is listed as actively marketed, with no marketing end date reported by CVS Pharmacy. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CVS Pharmacy 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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 16 words ▾

Uses temporarily relieves: cough as may occur with a cold ocassional minor irritation and sore throat

⏱️ Dosage and Administration 33 words ▾

Directions Adults and children 6 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor. Children under 6 years as a Doctor

⚠️ Warnings 40 words ▾

Warnings Sore throat warning: severe or persistence sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 12 years of age.

🆘 Overdosage 16 words ▾

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active Ingredient: Menthol 4.8 mg.............cough suppresant/ oral anesthetic Front Panel

🧪 Inactive Ingredients 26 words ▾

caramel color, blend of herb extracts (elderflower, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme. wild thyme) glucose syrup, natural flavors, sucrose Back Panel

🎯 Purpose 16 words ▾

Uses temporarily relieves: cough as may occur with a cold ocassional minor irritation and sore throat

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51316-0848-01 · CVS 51316-0851-01 · CVS →
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.