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ACETAMINOPHEN PM Acetaminophen, Diphenhydramine HCl 500 mg; 25 mg Tablet, Film Coated, 100-count — NDC 72288-0090-78 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ACETAMINOPHEN PM Acetaminophen, Diphenhydramine HCl 500 mg; 25 mg Tablet, Film Coated, 100-count — NDC 72288-090-78 (Billing 72288-0090-78)

by Amazon.com Services LLC · 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE

This is a package of 100 tablets of ACETAMINOPHEN PM Acetaminophen, Diphenhydramine HCl 500 mg; 25 mg Tablet, Film Coated from Amazon.com Services LLC, marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 72288-0090-78
🏷️ FDA NDC (as labeled) 72288-090-78 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 Sep 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72288-090-78
Product NDC 72288-090
11-digit billing NDC 72288009078
RxCUI 1092189
UNII 362O9ITL9D, TC2D6JAD40
Application # M013
SPL Set ID 99a137d6-07eb-43bc-b4b4-1a23041d595e
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-27
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1092189
Why two NDCs? The FDA registers this code as 72288-090-78 — 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 → 72288-0090-78. 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

🧪 What is this product?

Acetaminophen PM is an over-the-counter oral tablet that combines two active ingredients. Acetaminophen is commonly used to reduce fever and relieve minor aches and pains. Diphenhydramine hydrochloride is an antihistamine typically used to reduce itching and sneezing, and also functions as a sleep aid. This combination product is marketed under FDA's OTC monograph rules for nighttime pain and cold symptom relief.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Acetaminophen, Diphenhydramine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen, Diphenhydramine 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
72288-0090-78 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE 2026-08-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acetaminophen PM 500 mg/1; 25 mg 83324-0070-20 Chain 20 tablets $0.044 — Availability likely —
Extra Strength PM Pain Medicine 500 mg/1; 25 mg 46122-0799-69 Amerisource 50 tablets $0.044 — Availability likely —
good sense pain relief pm extra strength 500 mg/1; 25 mg 00113-0437-71 L. 50 tablets $0.044 — Availability likely —
Pain Reliever PM 500 mg/1; 25 mg 70677-1149-01 Strategic 50 tablets $0.044 — Availability likely —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 62011-0420-01 Strategic 50 tablets $0.046 — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 70677-0081-01 Strategic 100 tablets $0.046 — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 62011-0256-01 Strategic 50 tablets $0.047 — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 55910-0834-01 DOLGENCORP, 100 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 36800-0466-10 TOP 100 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 50594-0863-10 Big 100 tablets — — Discontinued —
CAREALL Non-Aspirin PM Extra Strength 500 mg/1; 25 mg 51824-0069-50 New 50 tablets — — FDA listed —
dg health pain relief pm extra strength 500 mg/1; 25 mg 55910-0437-71 Dolgencorp 50 tablets — — FDA listed —
Acetaminophen PM 500 mg/1; 25 mg 63981-0056-54 COSTCO 375 tablets — — FDA listed —
basic care acetaminophen pm 500 mg/1; 25 mg 72288-0437-78 Amazon.com 100 tablets — — FDA listed —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 41163-0228-50 United 50 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 49035-0363-10 EQUATE 100 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 50844-0235-15 L.N.K. 50 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 50844-0556-10 L.N.K. 40 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 51316-0863-50 CVS 500 tablets — — FDA listed —
Extra Strength Night Time Pain Medicine 500 mg/1; 25 mg 57896-0224-01 Geri-Care 100 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 68391-0863-05 BJWC 500 tablets — — FDA listed —
Extra Strength Pain Reliever PM 500 mg/1; 25 mg 62936-0224-01 INGLES 50 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 00363-0556-09 Walgreen 20 tablets — — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 36800-0556-09 Topco 20 tablets — — FDA listed —
CareOne Acetaminophen PM 500 mg/1; 25 mg 41520-0514-47 American 150 tablets — — Discontinued —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 41520-0956-09 FOODHOLD 20 tablets — — FDA listed —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 55301-0235-06 ARMY 200 tablets — — Discontinued —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 63868-0210-20 CHAIN 20 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 50844-0256-08 L.N.K. 24 tablets — — FDA listed —
CAREALL Pain Relief PM Extra Strength 500 mg/1; 25 mg 51824-0108-50 New 50 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 57243-0235-15 Salado 50 tablets — — FDA listed —
Pain Reliever PM Extra Strength 500 mg/1; 25 mg 00363-0760-10 Walgreens 100 tablets — — FDA listed —
Pain Reliever PM Extra strength 500 mg/1; 25 mg 00363-0863-10 Walgreens 100 tablets — — FDA listed —
acetaminophen pm extra strength 500 mg/1; 25 mg 68196-0556-54 Sam's 375 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 69607-8630-01 WR 24 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 11673-0754-10 TARGET 100 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 55319-0562-10 Family 100 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 63868-0119-50 QUALITY 50 tablets — — FDA listed —
Cystex PM 500 mg/1; 25 mg 69693-0417-10 Clarion 10 tablets — — FDA listed —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 69842-0956-09 CVS 20 tablets — — Discontinued —
Pain Reliever PM 500 mg/1; 25 mg 79903-0307-10 WALMART 100 tablets — — FDA listed —
Acetaminophen PM Extra Strength 500 mg/1; 25 mg 41163-0956-09 United 20 tablets — — FDA listed —
CAREALL Pain Relief PM Extra Strength 500 mg/1; 25 mg 51824-0107-50 New 50 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 79903-0050-09 WALMART 20 tablets — — FDA listed —
good sense pain relief pm extra strength 500 mg/1; 25 mg 63629-5880-01 Bryant 14 tablets — — FDA listed —
Pain Reliever PM 500 mg/1; 25 mg 00363-2035-08 Walgreen 24 tablets — — FDA listed —
Pain Relief PM Extra Strength 500 mg/1; 25 mg 37808-0556-09 H 20 tablets — — FDA listed —
pain relief pm extra strength 500 mg/1; 25 mg 56062-0437-71 Publix 50 tablets — — FDA listed —
Pain Relief PM 500 mg/1; 25 mg 42507-0437-71 HyVee 50 tablets — — FDA listed —
Acetaminophen Pm 500 mg/1; 25 mgthis 72288-0090-78 Amazon.com 100 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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

Color Blue
ShapeOval
ImprintL437;PM
Size18 mm
ScoringNot scored
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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII 4AQJ3LG584
    A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statescarnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

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

LabelerAmazon.com Services LLC
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code72288
First marketedAug 2026
Product typeHuman Otc Drug
Portfolio345 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.

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 14 words ▾

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

⏱️ Dosage and Administration 45 words ▾

Directions • do not take more than directed (see overdose warning) adults and children 12 years and over • take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hours children under 12 years do not use

⚠️ 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. • with any other product containing diphenhydramine, even one used on skin • in children under 12 years of age • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland 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 will occur • avoid alcoholic drinks • do not drive a motor vehicle or operate machinery Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks.

Insomnia may be a symptom of serious underlying medical illness. • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 11 words ▾

Other information • store at 20-25 ° C (68-77 ° F)

🧪 Active Ingredient 12 words ▾

Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg

🧪 Inactive Ingredients 34 words ▾

Inactive ingredients carnauba wax, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

🎯 Purpose 5 words ▾

Purpose Pain reliever Nighttime sleep-aid

📄 Do Not Use 65 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. • with any other product containing diphenhydramine, even one used on skin • in children under 12 years of age • if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 32 words ▾

Ask a doctor before use if you have • liver disease • glaucoma • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland

📄 Ask a Doctor or Pharmacist Before Use If 22 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 22 words ▾

When using this product • drowsiness will occur • avoid alcoholic drinks • do not drive a motor vehicle or operate machinery

📄 Stop Use and Ask a Doctor If 64 words ▾

Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur 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 46 words ▾

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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? 1-800-719-9260

📄 Package Label / Principal Display Panel 38 words ▾

Principal Display Panel amazon basics Compare to Extra Strength Tylenol® PM active ingredients Extra Strength Acetaminophen PM Acetaminophen 500 mg Diphenhydramine HCl 25 mg For Adults Non-habit forming Pain Reliever / Nighttime Sleep-Aid 100 CAPLETS actual size amazon-basics-acetaminophen-pm-carton-image.jpg

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 Amazon.com Services LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amazon.com Services LLC 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.
← 72288-0080-09 · Amazon.com 72288-0101-48 · AMAZON.COM →
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.