Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Claritin Reditabs Loratadine 10 mg Tablet, Orally Disintegrating — NDC 11523-7157-7 (Billing 11523-7157-07)
by Bayer Healthcare LLC. · 4 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
This is a package of Claritin Reditabs Loratadine 10 mg Tablet, Orally Disintegrating from Bayer Healthcare LLC., marketed since Nov 2002 and currently FDA-listed.
NDC 11523-7157-07
🏷️ FDA NDC (as labeled)
11523-7157-7
billing pads the package segment with a zero
This package
Contains10 tablet, orally disintegrating in 1 blister pack
Pack sizes6 compare ↓
Product page 11523-7157-02
Also comes in:
10 tablets 11523-7157-2
10 tablets 11523-7157-3
10 tablets 11523-7157-4
10 tablets 11523-7157-8
10 tablets 11523-7157-9
🗂️ 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 11523-7157-7 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 11523 labeler · 7157 product · 7 package
- Package marketed since
- Nov 27, 2002
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 1152371577 8
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
11523-7157-7
Product NDC
11523-7157
11-digit billing NDC
11523715707
UNII
7AJO3BO7QN
Application #
NDA020704
SPL Set ID
b681ea25-d00b-4c8a-8054-cc6f983ce337
DEA schedule
Non-controlled
Marketing category
NDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2002-11-27
Route
ORAL
Dosage form
TABLET, ORALLY DISINTEGRATING
Substance
LORATADINE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
41550030007220
GPI class
Claritin Reditabs
GCN Seq No
030476
GCN
60521
HICL code
007605
Ingredient (HICL)
Loratadine
HIC1 code
Z
Therapeutic class — broad (HIC1)
Body As A Whole
HIC2 code
Z2
Therapeutic class — intermediate (HIC2)
Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code
Z2Q
Therapeutic class — specific (HIC3)
Antihistamines - 2Nd Generation
AHFS code
04:08.00.00
AHFS class
Second Generation Antihistamines
FDB label name
CLARITIN 10 MG REDITABS
FDB brand name
Claritin
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 030476
- GCN: 60521
- GPI-14 (Medi-Span): 41550030007220
- HICL (First Databank): 007605
- AHFS class code: 04:08.00.00
- RxCUI (RxNorm): 311373
Why two NDCs?
The FDA registers this code as 11523-7157-7 — a 5-4-1 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 package segment → 11523-7157-07. 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
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
Label name CLARITIN 10 MG REDITABS Ingredient Loratadine
📗 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 3, 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.
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 |
|---|---|---|---|---|
| 11523-7157-02 11523-7157-2 Main listing | 1 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2002-11-27 | — | Active |
| 11523-7157-03 11523-7157-3 | 3 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2002-11-27 | — | Active |
| 11523-7157-04 11523-7157-4 | 2 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2002-11-27 | — | Active |
| 11523-7157-07 You're viewing this | 4 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2002-11-27 | — | Active |
| 11523-7157-08 11523-7157-8 | 5 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2002-11-27 | — | Active |
| 11523-7157-09 11523-7157-9 | 7 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2002-11-27 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 4 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack.
What NDC number is used to bill for this package of Claritin Reditabs Loratadine 10 mg Tablet, Orally Disintegrating?
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 ODT 10 mg 00536-1367-07 | Rugby | 10 tablets | $0.527 | — | Availability likely | — |
| Loratadine ODT 10 mg 46122-0539-52 | Amerisource | 10 tablets | $0.527 | — | Availability likely | — |
| Loratadine 10 mg 72888-0029-09 | Advagen | 10 tablets | $0.527 | — | Availability likely | — |
| good sense allergy relief 10 mg 00113-1191-65 | L. | 1 tablet | — | — | FDA listed | — |
| good sense allergy relief 10 mg 00113-9755-65 | L. | 1 tablet | — | — | FDA listed | — |
| Childrens Loratadine Odt 10 mg 00363-4020-84 | WALGREEN | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 00363-9937-84 | WALGREEN | 10 tablets | — | — | FDA listed | — |
| Claritin Reditabs 10 mg 11523-4329-01 | Bayer | 10 tablets | — | — | FDA listed | — |
| Claritin Reditabs 10 mgthis 11523-7157-07 | Bayer | 10 tablets | — | — | FDA listed | — |
| loratadine 10 mg 11822-0558-00 | Rite | 1 tablet | — | — | FDA listed | — |
| loratadine 10 mg 11822-0919-00 | Rite | 1 tablet | — | — | Discontinued | — |
| Loratadine ODT 10 mg 21130-0221-84 | Better | 10 tablets | — | — | FDA listed | — |
| signature care allergy relief 10 mg 21130-0301-65 | Safeway | 1 tablet | — | — | Discontinued | — |
| signature care allergy relief 10 mg 21130-0452-65 | Safeway | 1 tablet | — | — | FDA listed | — |
| allergy relief 10 mg 30142-0446-65 | Kroger | 1 tablet | — | — | FDA listed | — |
| Topcare Allergy Relief 10 mg 36800-0853-65 | Topco | 1 tablet | — | — | FDA listed | — |
| non drowsy allergy relief 10 mg 41250-0890-65 | Meijer | 1 tablet | — | — | FDA listed | — |
| careone allergy relief 10 mg 41520-0510-65 | American | 1 tablet | — | — | FDA listed | — |
| Loratadine 10 mg 43598-0707-30 | Dr. | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mg 43598-0758-10 | Dr. | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 49035-0806-03 | Wal-Mart | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mg 51316-0503-01 | CVS | 10 tablets | — | — | FDA listed | — |
| Allergy Relief 10 mg 51316-0931-46 | CVS | 1 tablet | — | — | FDA listed | — |
| Allergy Relief 10 mg 51660-0527-31 | Ohm | 1 tablet | — | — | FDA listed | — |
| Loratadine ODT 10 mg 53943-0035-03 | DISCOUNT | 10 tablets | — | — | FDA listed | — |
| dg health allergy relief 10 mg 55910-0594-46 | Dolgencorp, | 1 tablet | — | — | FDA listed | — |
| dg health allergy relief 10 mg 55910-0970-46 | Dolgencorp, | 1 tablet | — | — | FDA listed | — |
| Allervarx 10 mg 57483-0950-10 | Innovus | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0744-83 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0821-83 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0830-83 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 58602-0881-15 | Aurohealth | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mg 59556-0917-01 | Strides | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 60000-0950-83 | Ahold | 10 tablets | — | — | FDA listed | — |
| Loratadine ODT 10 mg 68016-0088-10 | Chain | 10 tablets | — | — | FDA listed | — |
| Alavert Allergy 10 mg 69536-0190-60 | Foundation | 1 tablet | — | — | FDA listed | — |
| Alavert Allergy 10 mg 69536-0195-20 | Foundation | 1 tablet | — | — | FDA listed | — |
| Loratadine ODT 10 mg 69842-0085-03 | CVS | 10 tablets | — | — | FDA listed | — |
| Basic Care Allergy Relief 10 mg 72288-0200-65 | Amazon.com | 1 tablet | — | — | FDA listed | — |
| Basic Care Allergy Relief 10 mg 72288-0451-65 | Amazon.com | 1 tablet | — | — | FDA listed | — |
| Loratadine 10 mg 72983-0501-01 | Tenshi | 10 tablets | — | — | FDA listed | — |
| Loratadine 10 mg 72983-0503-06 | Tenshi | 1 tablet | — | — | FDA listed | — |
| equate loratadine 10 mg 79903-0381-10 | WALMART | 1 tablet | — | — | FDA listed | — |
| Alavert Allergy 10 mg 80070-0110-18 | Foundation | 1 tablet | — | — | FDA listed | — |
| Alavert Allergy 10 mg 80070-0120-60 | Foundation | 1 tablet | — | — | Discontinued | — |
| Allergy Relief 10 mg 79481-9723-01 | Meijer, | 1 tablet | — | — | FDA listed | — |
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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
🏛️
2002
On the market since
Nov 2002
📍
2026
Currently FDA-listed
24 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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
What it looks like
Color
white
ShapeRound
ImprintC10
Size12 mm
ScoringNot scored
FlavorMint
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.
- FDA label on DailyMed · label index 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 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
LabelerBayer Healthcare LLC.
Application holderBAYER HEALTHCARE LLC
FDA applicationNDA020704 (NDA)
Labeler code11523
First marketedNov 2002
Product typeHuman Otc Drug
Portfolio240 products on file
More NDCs from Bayer Healthcare LLC. labeler code 11523
- Children Claritin Allergy loratadine 5 mg/5mL Solution NDC 11523-4360-1
- Claritin Chewable Cool Mint Flavor loratadine 10 mg Tablet, Chewable NDC 11523-4364-1
- Coricidin HBP Day and Night Dextromethorphan Hydrobromide, Guaifenesin, Acetaminophen, Chlorpheniramine maleate Kit NDC 11523-4765-1
- Lotrimin Clotrimazole 10 mg/g Cream NDC 11523-6549-1
- Claritin Loratadine 10 mg Tablet NDC 11523-6655-1
- Afrin Severe Congestion Oxymetazoline hydrochloride .05 g/100mL Spray NDC 11523-7020-1
- Coricidin HBP Chest Congestion And Cough Dextromethorphan hydrobromide and Guaifenesin 10 mg; 200 mg Capsule, Gelatin Coated NDC 11523-7158-2
- Claritin Loratadine 10 mg Tablet NDC 11523-7160-1
- Claritin-D 12 Hour Loratadine and pseudoephedrine sulfate 5 mg; 120 mg Tablet, Extended Release NDC 11523-7162-1
- Claritin Liqui-Gels Loratadine 10 mg Capsule, Liquid Filled NDC 11523-7200-1
- Claritin Reditabs Loratadine 5 mg Tablet, Orally Disintegrating NDC 11523-7202-1
- MiraLAX Polyethylene Glycol 3350 3350 17 g/17g Powder, For Solution NDC 11523-7234-1
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 place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 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.
📦 Storage and Handling ▾
Other information safety sealed: do not use if the individual blister unit imprinted with Claritin® RediTabs® is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Loratadine 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredients anhydrous citric acid, gelatin, mannitol, mint flavor
🎯 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.
📄 Questions or Comments ▾
Questions or comments? 1-800-CLARITIN (1-800-252-7484) or www.claritin.com
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 10 Tablet Carton Original Prescription Strength NDC 11523-7157-2 Non-Drowsy* Claritin ® RediTabs ® loratadine 10 mg/antihistamine Indoor & Outdoor Allergies *When taken as directed. See Drug Facts Panel. 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose No Water Needed Melts in Your Mouth 10 ORALLY DISINTEGRATING TABLETS PRINCIPAL DISPLAY PANEL - 10 Tablet Carton
PRINCIPAL DISPLAY PANEL - 60 Tablet Twin Pack Carton TWIN PACK Two 30ct Cartons 60 RediTabs ® Original Prescription Strength NDC 11523-4329-1 Non-Drowsy* Claritin ® RediTabs ® loratadine 10 mg/antihistamine Indoor & Outdoor Allergies *When taken as directed. See Drug Facts Panel. 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose No Water Needed Melts in Your Mouth 60 ORALLY DISINTEGRATING TABLETS PRINCIPAL DISPLAY PANEL - 60 Tablet Twin Pack Carton
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 Claritin Reditabs (this brand).
Top reported reactions
Reporter sex
Male · 34%
Female · 66%
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 | ✓ Available |
| 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 Bayer Healthcare 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 5 other package presentations of this same product, including 10 tablets (11523-7157-02), 10 tablets (11523-7157-03), 10 tablets (11523-7157-04). 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?
Bayer Healthcare 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.