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Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate 500 mg; 60 mg; 15 mg Tablet, Film Coated, 24-count — NDC 50804-990-08 (Billing 50804-0990-08)

by Geiss, Destin & Dunn Inc. · 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 24 tablets of Menstrual Relief Acetaminophen, Caffeine, Pyrilamine maleate 500 mg; 60 mg; 15 mg Tablet, Film Coated from Geiss, Destin & Dunn Inc., marketed since Mar 2020 and currently FDA-listed. It is this product's only package size.

NDC 50804-0990-08
🏷️ FDA NDC (as labeled) 50804-990-08 billing pads the product segment with a zero
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 50804-990-08 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
50804 labeler · 990 product · 08 package
Package marketed since
Mar 24, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
24 EA per package
Barcode (UPC)
0846036006582
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50804-990-08
Product NDC 50804-990
11-digit billing NDC 50804099008
NCPDP billing unit EA — each (per item)
RxCUI 1597298
UNII 362O9ITL9D, 3G6A5W338E, R35D29L3ZA
UPC 0846036006582
Application # M027
SPL Set ID bf85fb32-66d4-4683-be9d-58ca4e9f272d
Established class (EPC) Central Nervous System Stimulant; Methylxanthine
Physiologic effect Central Nervous System Stimulation
Chemical class Xanthines
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-03-24
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE

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

GCN Seq No 020181
GCN 72751
HICL code 008260
Ingredient (HICL) Acetaminophen/Pyrilamine/Caff
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B5
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.2)
HIC3 code B5Y
Therapeutic class — specific (HIC3) Analgesic,Non-Salicylate-1St Gen Antihist-Xanthine
AHFS code 04:04.08.00
AHFS class Ethylenediamine Derivatives
FDB label name GS MENSTRUAL RELIEF CAPLET
FDB brand name Menstrual Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 020181
  • GCN: 72751
  • HICL (First Databank): 008260
  • AHFS class code: 04:04.08.00
  • RxCUI (RxNorm): 1597298
Why two NDCs? The FDA registers this code as 50804-990-08 — 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 → 50804-0990-08. 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 Anilides class.

Drug family (ATC) Anilides
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 GS MENSTRUAL RELIEF CAPLET Ingredient Acetaminophen/Pyrilamine/Caff
🧪 What is this product?

This is an over-the-counter film-coated tablet taken by mouth that combines three active ingredients commonly used together in menstrual symptom products. Acetaminophen is typically used to relieve pain and reduce fever. Caffeine, a central nervous system stimulant, is commonly added to pain-relief formulas and may enhance their effects. Pyrilamine maleate is an antihistamine typically used to reduce bloating and other symptoms associated with menstrual discomfort.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
7
Nutrient depletion considerations

Acetaminophen, Caffeine, Pyrilamine may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen, Caffeine, Pyrilamine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50804-0990-08 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2020-03-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Midol Complete 500 mg/1; 60 mg/1; 15 mg 00280-8005-16 Bayer 16 tablets — — FDA listed —
Midol Complete Gelcaps 60 mg/1; 15 mg/1; 500 mg 00280-8015-24 Bayer 24 tablets — — FDA listed —
Menstrual Relief Maximum Strength 500 mg/1; 60 mg/1; 15 mg 00363-0252-21 Walgreen 8 tablets — — Discontinued —
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg 500 mg/1; 60 mg/1; 15 mg 00363-2310-24 WALGREENS 24 tablets — — FDA listed —
Menstrual Pain Relief 500 mg/1; 60 mg/1; 15 mg 00363-3900-10 Walgreen 40 tablets — — Discontinued —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 00363-3909-21 Walgreen 8 tablets — — FDA listed —
Menstrual Complete Pain Relief 500 mg/1; 60 mg/1; 15 mg 00363-9390-10 Walgreen 40 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 00924-6010-02 Acme 100 tablets — — FDA listed —
Multi-Symptom Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 11673-0363-64 TARGET 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 11673-0390-10 Target 40 tablets — — FDA listed —
Menstrual Complete Maximum Strength 500 mg/1; 60 mg/1; 15 mg 11822-0390-01 Rite 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 11822-3900-01 Rite 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 21130-0930-10 Better 40 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 29485-7964-02 Lil' 50 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 30142-0390-10 Kroger 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 36800-0391-08 Topco 24 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 37808-0389-10 H 40 tablets — — FDA listed —
Menstrual Relief Maximum Strength 500 mg/1; 60 mg/1; 15 mg 41163-0390-10 United 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 41163-0391-10 United 40 tablets — — FDA listed —
Comfort-Time 500 mg/1; 60 mg/1; 15 mg 49483-0347-24 Time 24 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 50269-0007-06 JC 12 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 50269-0009-06 JC 24 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mgthis 50804-0990-08 Geiss, 24 tablets — — FDA listed —
Menstrual Complete Maximum Strength 500 mg/1; 60 mg/1; 15 mg 50844-0390-19 L.N.K. 8 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 50844-0399-08 L.N.K. 24 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 51316-0390-10 CVS 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 53943-0390-10 Discount 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 55319-0301-21 Family 8 tablets — — FDA listed —
Dolex Fem 500 mg/1; 60 mg/1; 15 mg 55758-0326-25 Pharmadel 24 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 55910-0123-10 DOLGENCORP, 40 tablets — — FDA listed —
Menstrual Relief 500 mg/1; 60 mg/1; 15 mg 59779-0930-08 CVS 8 tablets — — FDA listed —
Menstrual Complete Maximum Strength 500 mg/1; 60 mg/1; 15 mg 63868-0032-24 CHAIN 24 tablets — — FDA listed —
Midol Complete, Travel BASIX 500 mg/1; 60 mg/1; 15 mg 66715-6445-02 Lil' 4 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 66715-9745-02 Lil' 4 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 67091-0334-40 WinCo 40 tablets — — FDA listed —
Midol 500 mg/1; 60 mg/1; 15 mg 67751-0145-01 Navajo 4 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 69168-0470-06 Allegiant 120 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 69517-0130-20 Healthlife 20 tablets — — FDA listed —
Buscapina 500 mg/1; 60 mg/1; 15 mg 69729-0130-24 OPMX 24 tablets — — FDA listed —
Buscapina 500 mg/1; 60 mg/1; 15 mg 69729-0131-72 OPMX 2 tablets — — FDA listed —
Buscapina 15 mg/1; 500 mg/1; 60 mg 69729-0132-06 OPMX 2 tablets — — FDA listed —
Buscapina 15 mg/1; 500 mg/1; 60 mg 69729-0818-50 OPMX 2 tablets — — FDA listed —
Midol Complete 15 mg/1; 500 mg/1; 60 mg 70264-0012-01 R 100 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 70692-0131-24 Strive 24 tablets — — FDA listed —
Menstrual Complete 60 mg/1; 15 mg/1; 500 mg 72090-0026-02 Pioneer 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 79481-0390-01 Meijer 40 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 79903-0266-40 WALMART 40 tablets — — FDA listed —
FLO PMS Complete 500 mg/1; 60 mg/1; 15 mg 83049-0489-08 O 24 tablets — — FDA listed —
Menstrual Pain Relief Complete 500 mg/1; 60 mg/1; 15 mg 83059-0006-01 Shield 15 tablets — — Discontinued —
Menstrual Pain Relief Complete 500 mg/1; 60 mg/1; 15 mg 83059-0105-01 Shield 15 tablets — — FDA listed —
Menstrual Pain Relief Complete 500 mg/1; 60 mg/1; 15 mg 83059-0119-08 Shield 80 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 83324-0017-24 Chain 24 tablets — — FDA listed —
Syncol Max 500 mg/1; 60 mg/1; 15 mg 83393-0390-02 Laboratorios 12 tablets — — FDA listed —
Midol Complete 500 mg/1; 60 mg/1; 15 mg 85237-1841-01 Select 2 tablets — — FDA listed —
Menstrual Complete 500 mg/1; 60 mg/1; 15 mg 41226-0348-44 Kroger 40 tablets — — 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

🏛️
2020
On the market since
Mar 2020
📍
2026
Currently FDA-listed
6 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.

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.

Manufacturer & labeler

LabelerGeiss, Destin & Dunn Inc.
FDA applicationM027 (OTC MONOGRAPH DRUG)
Labeler code50804
First marketedMar 2020
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from Geiss, Destin & Dunn Inc. labeler code 50804

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 📄 Do Not Use 📄 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 21 words ▾

Uses for the temporary relief of these symptoms associated with menstrual periods: bloating headache muscle aches cramps backache fatigue water-weight gain

⏱️ Dosage and Administration 39 words ▾

Directions do not take more than directed adults and children 12 years and over: take 2 caplets with water repeat every 6 hours, as needed do not exceed 6 caplets per day children under 12 years: ask a doctor

⚠️ Warnings ~2 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland liver disease a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children use caution when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart rate.

The recommended dose of this product contains about as much caffeine as a cup of coffee. Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition. 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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 20 words ▾

Other information see end flap for expiration date and lot number store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

🧪 Active Ingredient 15 words ▾

Active ingredients (in each caplet) Acetaminophen 500 mg Caffeine 60 mg Pyrilamine maleate 15 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients corn starch, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

🎯 Purpose 5 words ▾

Purpose Pain reliever Diuretic Antihistamine

📄 Do Not Use 43 words ▾

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 30 words ▾

Ask a doctor before use if you have difficulty in urination due to enlargement of the prostate gland liver disease a breathing problem such as emphysema or chronic bronchitis glaucoma

📄 Ask a Doctor or Pharmacist Before Use If 20 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers

📄 When Using This Product 76 words ▾

When using this product drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children use caution when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart rate. The recommended dose of this product contains about as much caffeine as a cup of coffee.

📄 Stop Use and Ask a Doctor If 41 words ▾

Stop use and ask a doctor if new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 43 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-426-9391

📄 Package Label / Principal Display Panel 106 words ▾

Principal Display Panel GOODSENSE® NDC 50804-990-08 Menstrual Relief Caplets Acetaminophen, Caffeine, Pyrilamine maleate • Pain Reliever • Diuretic • Antihistamine Multi-Symptom Relief of: • Cramps • Bloating • Fatigue • Backache • Headache 24 Caplets actual size *Compare to the active ingredients of Midol® Complete TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Midol® Complete.

50844 REV0623B39008 Distributed by: Perrigo Direct, Inc., Peachtree City, GA 30269 www.PerrigoDirect.com (1-800-426-9391) GoodSense® is a registered trademark of L. Perrigo Company. Good Sense 44-390 Good Sense 44-390

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Geiss, Destin & Dunn Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Geiss, Destin & Dunn 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.
← 50804-0955-08 · Geiss, 50809-0001-02 · Abilene →
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.