Cough Drops 5.4 mg Pastille, 30-count — NDC 50804-592-01 (Billing 50804-0592-01)
by Perrigo Direct, Inc. · 30 PASTILLE in 1 BAG
This is a package of 30 pastilles of Cough Drops 5.4 mg Pastille from Perrigo Direct, Inc., marketed since May 2023 and currently FDA-listed. It is this product's only package size.
NDC 50804-0592-01
🏷️ FDA NDC (as labeled)
50804-592-01
billing pads the product segment with a zero
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 50804-592-01 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 50804 labeler · 592 product · 01 package
- Package marketed since
- May 12, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 30 EA per package
- Barcode (UPC)
- 0846036009538
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
50804-592-01
Product NDC
50804-592
11-digit billing NDC
50804059201
NCPDP billing unit
EA — each (per item)
RxCUI
485287
UNII
L7T10EIP3A
UPC
0846036009538
Application #
M012
SPL Set ID
fb809c63-94f1-bb7a-e053-6294a90a0a39
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2023-05-12
Route
ORAL
Dosage form
PASTILLE
Substance
MENTHOL
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GCN Seq No
071387
GCN
35156
HICL code
002608
Ingredient (HICL)
Menthol
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
B3K
Therapeutic class — specific (HIC3)
Cough And/Or Cold Preparations
AHFS code
52:92.00.00
AHFS class
Eent Drugs, Miscellaneous
FDB label name
GS COUGH DROPS 5.4 MG
FDB brand name
Cough Drops
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 071387
- GCN: 35156
- HICL (First Databank): 002608
- AHFS class code: 52:92.00.00
- RxCUI (RxNorm): 485287
Why two NDCs?
The FDA registers this code as 50804-592-01 — 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 → 50804-0592-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Label name GS COUGH DROPS 5.4 MG Ingredient Menthol
📗 Our plain-language guide HelloPharmacist
- Mostly for temporary relief of minor aches and pains in muscles and joints, like those from arthritis, backache, strains, sprains and bruises. Some products are for other things, s...
- It depends on the product. Many creams, gels and patches are limited to about 3 to 4 times a day, and patches also have a time limit, often 8 hours. Follow your product label and a...
- A brief burning feeling can happen when you first apply it and usually fades in several days. But if you get severe burning pain, swelling or blistering, stop using it and call you...
- No. Don't use menthol products with a heating pad, and avoid local heat or direct sunlight on the area. Rare cases of serious burns have been reported.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
💬 Questions about Simply Menthol Cough Drops?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 4, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 50804-0592-01 You're viewing this Main listing | 30 PASTILLE in 1 BAG | 2023-05-12 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cough Drops Menthol 5.4 mg 70000-0638-01 | Cardinal | 30 pastilles | $0.034 | — | Availability likely | — |
| Menthol Cough Drop 5.4 mg 00363-1070-30 | Walgreens | 30 lozenges | — | — | FDA listed | — |
| Walgreens Menthol Cough Drops 5.4 mg 00363-9957-40 | Walgreens | 40 lozenges | — | — | FDA listed | — |
| Halls MENTHO-LYPTUS 5.4 mg 12546-0112-14 | Mondelez | 14 lozenges | — | — | Discontinued | — |
| HALLS Mentholyptus 5.4 mg 12546-0116-30 | Mondelez | 30 lozenges | — | — | FDA listed | — |
| Menthol Cough Drop 5.4 mg 21130-0265-30 | Safeway | 30 lozenges | — | — | FDA listed | — |
| Menthol cough drop 5.4 mg 30142-0031-30 | The | 30 lozenges | — | — | FDA listed | — |
| menthol cough drops 5.4 mg 36800-0814-30 | Topco | 30 lozenges | — | — | FDA listed | — |
| Menthol Cough Drop 5.4 mg 37808-0032-30 | HEB | 30 lozenges | — | — | FDA listed | — |
| HEB Menthol Cough Drops 5.4 mg 37808-0475-60 | HEB | 160 lozenges | — | — | FDA listed | — |
| Menthol Cough Drops 5.4 mg 41250-0082-00 | Meijer | 200 lozenges | — | — | FDA listed | — |
| menthol cough drops 5.4 mg 41250-0149-04 | Meijer | 30 lozenges | — | — | FDA listed | — |
| menthol cough drops 5.4 mg 41520-0009-30 | American | 30 lozenges | — | — | FDA listed | — |
| HyVee Cough Drops Menthol 5.4 mg 42507-0905-30 | HY-VEE, | 30 lozenges | — | — | FDA listed | — |
| GoodSense Menthol Cough Drops 5.4 mg 50804-0013-30 | Geiss, | 30 lozenges | — | — | FDA listed | — |
| Cough Drops 5.4 mgthis 50804-0592-01 | Perrigo | 30 pastilles | — | — | FDA listed | — |
| Menthol Cough Drops 5.4 mg 52642-0042-30 | Bestco | 30 lozenges | — | — | FDA listed | — |
| Best Health Menthol Cough Drops 5.4 mg 52642-0055-80 | Bestco | 80 lozenges | — | — | FDA listed | — |
| Discount Drug Mart 5.4 mg 53943-0102-30 | DISCOUNT | 30 lozenges | — | — | FDA listed | — |
| Menthol Flavor Cough Drop 5.4 mg 55301-0581-30 | Army | 30 lozenges | — | — | FDA listed | — |
| Exchange Select Cough Drops Menthol Sugar Free 5.4 mg 55301-0584-25 | Army | 25 lozenges | — | — | FDA listed | — |
| Menthol cough drops 5.4 mg 55319-0006-30 | Family | 30 lozenges | — | — | FDA listed | — |
| Cough Drops 5.4 mg 59450-0713-01 | The | 30 pastilles | — | — | FDA listed | — |
| Cough Drops 5.4 mg 59450-0714-01 | The | 200 pastilles | — | — | FDA listed | — |
| menthol cough drops 5.4 mg 67091-0300-80 | Winco | 80 lozenges | — | — | FDA listed | — |
| Premier Value 5.4 mg 68016-0885-30 | Pharmacy | 4 lozenges | — | — | FDA listed | — |
| CVS Menthol Cough Drops 5.4 mg 69842-0536-60 | CVS | 160 lozenges | — | — | FDA listed | — |
| Freegells Cough Drops Menthol Eucalyptus 5.4 mg 71165-0012-00 | Riclan | 30 lozenges | — | — | FDA listed | — |
| Harris Teeter Menthol Cough Drops 5.4 mg 72036-0085-30 | Harris | 30 lozenges | — | — | FDA listed | — |
| Menthol Cough Drops 5.4 mg 72628-0118-01 | BOSTON | 30 pastilles | — | — | FDA listed | — |
| Cough Drops Dollar General Menthol 30ct 5.4 mg 75712-0017-01 | Dollar | 270 lozenges | — | — | FDA listed | — |
| Cough Drops Dollar General Menthol 80ct 5.4 mg 75712-0021-01 | Dollar | 480 lozenges | — | — | FDA listed | — |
| Cough Drops Dollar General Menthol 160ct 5.4 mg 75712-0023-01 | Dollar | 640 lozenges | — | — | FDA listed | — |
| Cough Drops 5.4 mg 76162-0011-01 | Topco | 30 pastilles | — | — | FDA listed | — |
| Equate Menthol Cough Drops 5.4 mg 79903-0253-30 | Walmart | 30 lozenges | — | — | FDA listed | — |
| Freegells Cough Drops Menthol 80ct 5.4 mg 83002-0004-01 | R.L. | 480 lozenges | — | — | FDA listed | — |
| Freegells Cough Drops Menthol 30ct 5.4 mg 83002-0005-01 | R.L. | 270 lozenges | — | — | FDA listed | — |
| MGC Cough Drops 5.4 mg 83173-0109-30 | Medical | 30 lozenges | — | — | FDA listed | — |
| MGC Health 5.4 mg 83173-0113-25 | Medical | 25 lozenges | — | — | FDA listed | — |
| Quality Choice Menthol Cough Drops 5.4 mg 83324-0265-30 | Chain | 30 lozenges | — | — | FDA listed | — |
| Cough Drops 5.4 mg 83455-0206-01 | United | 30 pastilles | — | — | FDA listed | — |
| Discount Drug Mart 5.4 mg 83698-0102-30 | Xiamen | 30 lozenges | — | — | FDA listed | — |
| MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops 5.4 mg 83698-0110-30 | Xiamen | 30 lozenges | — | — | FDA listed | — |
| MGC Health 5.4 mg 83698-0113-25 | Xiamen | 25 lozenges | — | — | FDA listed | — |
| Menthol Flavor Cough Drop 5.4 mg 83698-0581-30 | Xiamen | 30 lozenges | — | — | FDA listed | — |
| Exchange Select Cough Drops Menthol Sugar Free 5.4 mg 83698-0584-25 | Xiamen | 25 lozenges | — | — | FDA listed | — |
| Quality Choice 5.4 mg 83698-0675-30 | Xiamen | 30 lozenges | — | — | FDA listed | — |
| Premier Value 5.4 mg 83698-0885-30 | Xiamen | 4 lozenges | — | — | FDA listed | — |
| HyVee Cough Drops Menthol 5.4 mg 83698-0901-30 | Xiamen | 30 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Oct 3, 2026
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 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 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.
2 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesglucose syrup, 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.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerPerrigo Direct, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code50804
First marketedMay 2023
Product typeHuman Otc Drug
Portfolio4 products on file
More NDCs from Perrigo Direct, Inc. labeler code 50804
- Good Sense Effervescent Pain Relief Aspirin 325 mg Tablet, Effervescent NDC 50804-422-36
- Stool Softener 100 mg Capsule, Liquid Filled NDC 50804-424-25
- Mucus Relief DM Immediate Release 20 mg; 400 mg Tablet NDC 50804-432-30
- Cold and Flu Severe Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated NDC 50804-503-08
- Cold Multi-Symptom Daytime and Nighttime Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride Kit NDC 50804-551-02
- Cough Drops 5.8 mg Pastille NDC 50804-591-01
- Cough Drops Simply Honey Lemon 7.5 mg Pastille NDC 50804-593-01
- Eye Itch Relief Ketotifen Fumarate .25 mg/mL Solution/ Drops NDC 50804-601-05
- MAXIMUM STRENGTH ANTACID AND GASRELIEF aluminum hydroxide, magnesium hydroxide, dimethicone 800 mg/10mL; 800 mg/10mL; 80 mg/10mL Suspension NDC 50804-619-12
- ANTACID AND GASRELIEF aluminum hydroxide, magnesium hydroxide, dimethicone 400 mg/10mL; 400 mg/10mL; 40 mg/10mL Suspension NDC 50804-629-12
- ANTACID AND GASRELIEF aluminum hydroxide, magnesium hydroxide, simethicone 800 mg/10mL; 800 mg/10mL; 80 mg/10mL Liquid NDC 50804-638-12
- ADVANCED ANTACID MINT aluminum hydroxide, magnesium hydroxide, dimethicone 400 mg/10mL; 400 mg/10mL; 40 mg/10mL Suspension NDC 50804-639-12
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Ask a Doctor Before Use If
📄 Stop Use and Ask a Doctor If
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Other Information
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses temporarily relieves: cough as may occur with a cold ocassional minor irritation and sore throat
⏱️ Dosage and Administration ▾
Directions Adults and children 12 years and over: dissolve 1 drop slowly in mouth. Repeated every 2 hours as needed or as directed by a doctor. Children under 12 years and under do not use
⚠️ Warnings ▾
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 ▾
In case of accidental overdose, get medical help or contact a Poison Control Center right away.
🧪 Active Ingredient ▾
Active Ingredient Menthol 5.4 mg cough suppresant oral anesthetic Front Panel
🧪 Inactive Ingredients ▾
glucose syrup, sucrose Back Panel
🎯 Purpose ▾
Uses temporarily relieves: cough as may occur with a cold ocassional minor irritation and sore throat
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have a severe throat accompanied by difficulty in breathing or that last more than 2 days a sore throat accompanied by fever, headache, rash, swelling, nausea or vomiting
📄 Stop Use and Ask a Doctor If ▾
Stop use and consult a doctor if sore mouth symptons do not improve in 7 days or if irritation, pains or redness persists or worsens.
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep this and all drugs out of the reach of children.
📄 Other Information ▾
Store in a cool and dry place 10 calories per drop
📄 Questions or Comments ▾
Questions or comments: 1-855-423-2630
📄 Package Label / Principal Display Panel ▾
Back
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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 Cough Drops (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 38%
Female · 62%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
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) | — 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 Perrigo Direct, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Perrigo Direct, 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.
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.