Basic Care Childrens Allergy Relief loratadine 5 mg Tablet, Chewable — NDC 72288-901-49 (Billing 72288-0901-49)
by Amazon.com Services LLC · 40 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK
This is a package of Basic Care Childrens Allergy Relief loratadine 5 mg Tablet, Chewable from Amazon.com Services LLC, marketed since Aug 2021 and currently FDA-listed.
NDC 72288-0901-49
🏷️ FDA NDC (as labeled)
72288-901-49
billing pads the product segment with a zero
This package
Contains1 tablet, chewable in 1 blister pack
Pack sizes2 compare ↓
🗂️ 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 72288-901-49 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 72288 labeler · 901 product · 49 package
- Package marketed since
- Aug 12, 2021
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 7228890149 3
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
72288-901-49
Product NDC
72288-901
11-digit billing NDC
72288090149
RxCUI
665078
UNII
7AJO3BO7QN
Application #
ANDA210033
SPL Set ID
e2c83874-aa95-477a-9cfd-cecfd776ba0e
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2021-08-12
Route
ORAL
Dosage form
TABLET, CHEWABLE
Substance
LORATADINE
Quick answers
- RxCUI (RxNorm): 665078
Why two NDCs?
The FDA registers this code as 72288-901-49 — 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 → 72288-0901-49. 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 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Other antihistamines for systemic use class.
Drug family (ATC)
Other antihistamines for systemic use
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
📗 Our plain-language guide HelloPharmacist
- It temporarily relieves symptoms of hay fever and other upper respiratory allergies. That means runny nose, sneezing, itchy, watery eyes, and an itchy nose or throat.
- It is taken by mouth, generally once a day. Follow the directions on your specific product. Chewable tablets should be chewed or crushed completely, and liquids should be measured...
- No. Do not take more than directed. Taking more than directed may cause drowsiness. If you think you took too much, get medical help or call Poison Control right away.
- Can I take extra if my allergies are bad?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Loratadine — tap one for details:
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 5, 2026
💬 Questions about loratadine?
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.
Try another pack size:
1 tablet
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 5, 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 |
|---|---|---|---|---|
| 72288-0901-01 72288-901-01 Main listing | 20 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK | 2021-08-12 | — | Active |
| 72288-0901-49 You're viewing this | 40 BLISTER PACK in 1 CARTON / 1 TABLET, CHEWABLE in 1 BLISTER PACK | 2021-08-12 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 40 blister pack in 1 carton / 1 tablet, chewable in 1 blister pack.
What NDC number is used to bill for this package of Basic Care Childrens Allergy Relief loratadine 5 mg Tablet, Chewable?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Loratadine 5 mg 51660-0753-31 | Ohm | 10 tablets | $0.404 | — | FDA listed | — |
| Childrens Loratadine 5 mg 51660-0754-31 | Ohm | 10 tablets | $0.511 | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 51660-0112-31 | Ohm | 10 tablets | $0.521 | — | Availability likely | — |
| foster and thrive childrens allergy relief 5 mg 70677-1043-01 | Strategic | 1 tablet | $0.521 | — | Availability likely | — |
| good sense childrens allergy relief 5 mg 00113-1019-39 | L. | 1 tablet | — | — | Discontinued | — |
| Loratadine 5 mg 00363-0752-30 | WALGREEN | 10 tablets | — | — | FDA listed | — |
| Wal-itin 5 mg 00363-0754-30 | Walgreens | 10 tablets | — | — | FDA listed | — |
| Loratadine 5 mg 00363-9985-30 | WALGREENS | 10 tablets | — | — | FDA listed | — |
| Wal-itin 5 mg 00363-9995-30 | WALGREENS | 10 tablets | — | — | FDA listed | — |
| Claritin 5 mg 11523-0104-01 | Bayer | 10 tablets | — | — | FDA listed | — |
| Claritin Chewable Grape and Bubblegum 11523-0123-01 | Bayer | 1 kit | — | — | FDA listed | — |
| Claritin 5 mg 11523-4328-01 | Bayer | 10 tablets | — | — | FDA listed | — |
| Claritin 5 mg 11523-4330-01 | Bayer | 10 tablets | — | — | FDA listed | — |
| Claritin 5 mg 11523-4331-01 | Bayer | 10 tablets | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 11673-0111-30 | UP | 10 tablets | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 11673-0115-30 | UP | 10 tablets | — | — | FDA listed | — |
| Childrens Loratadine 5 mg 11673-0310-30 | TARGET | 10 tablets | — | — | FDA listed | — |
| Childrens Allergy 5 mg 11673-0996-30 | TARGET | 10 tablets | — | — | FDA listed | — |
| Childrens Loratadine 5 mg 11673-0997-30 | TARGET | 10 tablets | — | — | FDA listed | — |
| childrens allergy relief 5 mg 11822-0801-01 | Rite | 1 tablet | — | — | FDA listed | — |
| Loratadine 5 mg 11822-7240-00 | Rite | 30 tablets | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 11822-8329-07 | RITE | 10 tablets | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 11822-9999-03 | RITE | 10 tablets | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 21130-0646-20 | SAFEWAY | 10 tablets | — | — | FDA listed | — |
| Childrens Loratadine 5 mg 21130-0963-20 | SAFEWAY | 10 tablets | — | — | FDA listed | — |
| Childrens Loratadine 5 mg 21130-0999-20 | SAFEWAY | 10 tablets | — | — | FDA listed | — |
| Loratadine 5 mg 30142-0565-30 | KROGER | 10 tablets | — | — | FDA listed | — |
| Loratadine 5 mg 30142-0984-30 | KROGER | 10 tablets | — | — | FDA listed | — |
| Loratadine 5 mg 30142-0996-30 | KROGER | 10 tablets | — | — | FDA listed | — |
| topcare childrens allergy relief 5 mg 36800-0363-39 | Topco | 1 tablet | — | — | FDA listed | — |
| Childrens Allergy Relief 5 mg 37808-0506-39 | H | 1 tablet | — | — | FDA listed | — |
| Equaline Childrens Allergy Relief 5 mg 41163-0364-01 | United | 1 tablet | — | — | FDA listed | — |
| childrens allergy relief 5 mg 41250-0629-39 | Meijer | 1 tablet | — | — | FDA listed | — |
| careone childrens allergy relief 5 mg 41520-0716-01 | American | 1 tablet | — | — | FDA listed | — |
| Childrens Loratadine 5 mg 46122-0550-60 | Amerisource | 10 tablets | — | — | Discontinued | — |
| Loratadine 5 mg 49035-0953-30 | Wal-Mart | 10 tablets | — | — | FDA listed | — |
| childrens allergy relief 5 mg 51316-0133-52 | CVS | 1 tablet | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 51316-0821-20 | CVS | 10 tablets | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 51660-0726-30 | Ohm | 10 tablets | — | — | FDA listed | — |
| dg health childrens allergy relief 5 mg 55910-0807-52 | Dolgencorp, | 1 tablet | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 56062-0900-20 | PUBLIX | 10 tablets | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 56062-0921-20 | PUBLIX | 10 tablets | — | — | FDA listed | — |
| Loratadine 5 mg 56062-0990-20 | PUBLIX | 10 tablets | — | — | FDA listed | — |
| Loratadine 5 mg 68016-0053-10 | Premier | 10 tablets | — | — | FDA listed | — |
| Berkley and Jensen Childrens Allergy Relief 5 mg 68391-0301-49 | BJWC | 1 tablet | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 69842-0894-30 | CVS | 10 tablets | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 69842-0895-20 | CVS | 10 tablets | — | — | FDA listed | — |
| Childrens Loratadine 5 mg 69842-0953-20 | CVS | 10 tablets | — | — | FDA listed | — |
| Childrens Loratadine 5 mg 69842-0954-30 | CVS | 10 tablets | — | — | FDA listed | — |
| Basic Care Childrens Allergy Relief 5 mgthis 72288-0901-49 | Amazon.com | 1 tablet | — | — | FDA listed | — |
| Curist Childrens Allergy Relief 5 mg 72559-0031-43 | Little | 10 tablets | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 79903-0008-30 | WAL-MART | 10 tablets | — | — | FDA listed | — |
| Dye-Free Childrens Loratadine 5 mg 79903-0330-30 | WAL-MART | 10 tablets | — | — | FDA listed | — |
| Loratadine 5 mg 00363-9994-30 | WALGREENS | 10 tablets | — | — | FDA listed | — |
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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
🏛️
2021
On the market since
Aug 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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.
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.- FDA label on DailyMed · label index refreshed Oct 5, 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
LabelerAmazon.com Services LLC
Application holderPERRIGO PHARMA INTERNATIONAL DESIGNATED ACTIVITY CO
FDA applicationANDA210033 (ANDA)
Labeler code72288
First marketedAug 2021
Product typeHuman Otc Drug
Portfolio345 products on file
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- basic care childrens ibuprofen 100 mg/5mL Suspension NDC 72288-897-26
- basic care esomeprazole magnesium 20 mg Capsule, Delayed Release NDC 72288-898-01
- basic care childrens cough dm Dextromethorphan polistirex 30 mg/5mL Suspension NDC 72288-899-28
- Isopropyl Alcohol 91 mL/100mL Liquid NDC 72288-904-43
- Everyday Clean Pyrithione zinc 10 mg/mL Shampoo NDC 72288-911-15
- basic care omeprazole 20 mg Tablet, Delayed Release NDC 72288-915-01
- Witch Hazel 860 mg/mL Liquid NDC 72288-922-26
- Flushable Hemorrhoidal Medicated Wipes Maximum Strength Witch Hazel .5 g Cloth NDC 72288-923-01
- Sheer Touch Sunscreen SPF 30 Avobenzone, Homosalate, Octisalate 50 mg/mL; 30 mg/mL; 100 mg/mL Lotion NDC 72288-932-21
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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Do Not Use
📄 Ask a Doctor 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 ▾
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • itchy, watery eyes • sneezing • itching of the nose or throat
⏱️ Dosage and Administration ▾
Directions • chew or crush tablets completely before swallowing adults and children 6 years and over chew 2 tablets daily; not more than 2 tablets in 24 hours children 2 to under 6 years of age chew 1 tablet daily; not more than 1 tablet in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor
⚠️ Warnings ▾
Warnings Do not use 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 or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed.
Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
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 (1-800-222-1222).
📦 Storage and Handling ▾
Other information • phenylketonurics: contains phenylalanine 1.4 mg per tablet • do not use if blister unit is broken or torn • store between 20 ° to 25 ° C (68 ° to 77 ° F)
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Loratadine 5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients artificial grape flavor, aspartame, colloidal silicon dioxide, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate, stearic acid
🎯 Purpose ▾
Purpose Antihistamine
📄 Do Not Use ▾
Do not use if you have ever had an allergic reaction to this product or any of its ingredients
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
📄 When Using This Product ▾
When using this product do not take more than directed. Taking more than directed may cause drowsiness.
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
📄 Questions or Comments ▾
Questions or comments? 1-800-719-9260
📄 Package Label / Principal Display Panel ▾
Principal Display Panel Ages 2 Years and Older Compare to Children’s Claritin® Chewables active ingredient Children’s Allergy Relief Loratadine Chewable Tablets, 5 mg Antihistamine Indoor & Outdoor Allergies Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose *When taken as directed. See Drug Facts Panel. Grape Flavor actual size 40 CHEWABLE TABLETS Children's Allergy Relief Carton Image 1 Children's Allergy Relief Carton Image 2
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 basic care childrens allergy relief (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 37%
Female · 63%
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) | — 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
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 tablet (72288-0901-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
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.
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.