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FLONASE Headache and Allergy Relief acetaminophen, chlorpheniramine maleate, phenylephrine hcl 325 mg; 2 mg; 5 mg Tablet, 12-count — NDC 00135-0578-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

FLONASE Headache and Allergy Relief acetaminophen, chlorpheniramine maleate, phenylephrine hcl 325 mg; 2 mg; 5 mg Tablet, 12-count — NDC 0135-0578-01 (Billing 00135-0578-01)

by Haleon US Holdings LLC · 1 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK

This is a package of 12 tablets of FLONASE Headache and Allergy Relief acetaminophen, chlorpheniramine maleate, phenylephrine hcl 325 mg; 2 mg; 5 mg Tablet from Haleon US Holdings LLC, marketed since Mar 2022 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 00135-0578-01
🏷️ FDA NDC (as labeled) 0135-0578-01 billing pads the labeler segment with a zero
This package
Contains12-count Pack sizes3 compare ↓
Main listing for product 0135-0578 · Also comes in: 192 tablets 0135-0578-02 768 tablets 0135-0578-03
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 0135-0578-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0135 labeler · 0578 product · 01 package
Package marketed since
Mar 10, 2022
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
12 EA per package
Barcode (UPC-A, from the NDC)
3 0135057801 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0135-0578-01
Product NDC 0135-0578
11-digit billing NDC 00135057801
NCPDP billing unit EA — each (per item)
RxCUI 1046781
UNII 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ
Application # M012
SPL Set ID 282c103c-3888-4a35-a5b1-d492ed6892c1
Established class (EPC) Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; 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 2022-03-10
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE

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

GCN Seq No 047013
GCN 85915
HICL code 000435
Ingredient (HICL) Phenylephrine/Acetaminophn/Cpm
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B3
Therapeutic class — intermediate (HIC2) Drugs Affecting Primarily The Trachea And Bronchi
HIC3 code B3O
Therapeutic class — specific (HIC3) 1St Gen Antihistamine-Decongestant-Analgesic Comb
AHFS code 04:04.00.00
AHFS class First Generation Antihistamines
FDB label name FLONASE HEADACHE 325-2-5MG CPT
FDB brand name Flonase Headache-Allergy Rlf
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 047013
  • GCN: 85915
  • HICL (First Databank): 000435
  • AHFS class code: 04:04.00.00
  • RxCUI (RxNorm): 1046781
Why two NDCs? The FDA registers this code as 0135-0578-01 — a 4-4-2 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 labeler segment → 00135-0578-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

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 FLONASE HEADACHE 325-2-5MG CPT Ingredient Phenylephrine/Acetaminophn/Cpm
🧪 What is this product?

Flonase Headache and Allergy Relief is an over-the-counter oral tablet containing three active ingredients. Acetaminophen is typically used to reduce fever and relieve minor aches and pain. Chlorpheniramine maleate is a first-generation antihistamine commonly used to reduce allergy symptoms such as sneezing, itching, and runny nose. Phenylephrine hydrochloride is a nasal decongestant typically used to relieve nasal congestion related to allergies or colds.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.
Try another pack size: 192 tablets 768 tablets
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
00135-0578-01 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK 2022-03-10 — Active
00135-0578-02 0135-0578-02 4 BLISTER PACK in 1 CARTON / 48 TABLET in 1 BLISTER PACK 2022-03-10 — Active
00135-0578-03 0135-0578-03 8 BLISTER PACK in 1 CARTON / 96 TABLET in 1 BLISTER PACK 2022-03-10 — Active

Pack size FAQ

What quantity is in this package?
This is a 12-count package — 1 blister pack in 1 carton / 12 tablet in 1 blister pack.
How does this package differ from NDC 00135-0578-02?
Both are FLONASE Headache and Allergy Relief acetaminophen, chlorpheniramine maleate, phenylephrine hcl 325 mg; 2 mg; 5 mg Tablet — the drug itself is identical. This page's package is the 12-count one, while NDC 00135-0578-02 is the 192 tablets package.
What NDC number is used to bill for this package of FLONASE Headache and Allergy Relief acetaminophen, chlorpheniramine maleate, phenylephrine hcl 325 mg; 2 mg; 5 mg Tablet?
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 46122-0660-62 AMERISOURCE 12 tablets $0.086 — Availability likely —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 70000-0211-01 Cardinal 12 tablets $0.086 — Availability likely —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 70677-1004-01 STRATEGIC 12 tablets $0.086 — Availability likely —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 83324-0086-24 CHAIN 12 tablets $0.086 — Availability likely —
FLONASE Headache and Allergy Relief 325 mg/1; 2 mg/1; 5 mgthis 00135-0578-01 Haleon 12 tablets — — FDA listed —
Multi-Symptom Allergy 325 mg/1; 2 mg/1; 5 mg 00363-0559-08 Walgreen 12 tablets — — FDA listed —
PhysiciansCare Allergy Multi-Symptom Relief 325 mg/1; 2 mg/1; 5 mg 00924-0091-01 Acme 2 tablets — — FDA listed —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 36800-0628-02 TOPCO 12 tablets — — FDA listed —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 37808-0628-02 HEB 12 tablets — — FDA listed —
Medique Medicidin D 325 mg/1; 2 mg/1; 5 mg 47682-0120-13 Unifirst 2 tablets — — FDA listed —
Otis Clapp Valihist 325 mg/1; 2 mg/1; 5 mg 47682-0543-03 Unifirst 2 tablets — — FDA listed —
Relief-PE 325 mg/1; 5 mg/1; 2 mg 50332-0153-04 HART 100 tablets — — FDA listed —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 50804-0128-02 GOODSENSE 12 tablets — — FDA listed —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 50844-0455-08 L.N.K. 12 tablets — — FDA listed —
Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0005-01 FORTUNE 24 tablets — — FDA listed —
Extra Fast Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0010-01 FORTUNE 24 tablets — — FDA listed —
Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0011-01 FORTUNE 24 tablets — — FDA listed —
Extra Fast Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0014-01 FORTUNE 24 tablets — — FDA listed —
Defensol D 325 mg/1; 2 mg/1; 5 mg 53145-0005-02 Menper 100 tablets — — FDA listed —
Allergy Multisymptom 325 mg/1; 2 mg/1; 5 mg 53943-0228-02 DISCOUNT 12 tablets — — FDA listed —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 55301-0455-08 ARMY 12 tablets — — FDA listed —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 55910-0455-08 DOLGENCORP, 12 tablets — — FDA listed —
Allergy Multi Symptom 5 mg/1; 325 mg/1; 2 mg 57344-0928-02 AAA 12 tablets — — FDA listed —
Cold Medicine 325 mg/1; 2 mg/1; 5 mg 63654-0275-20 Selder, 20 tablets — — FDA listed —
Cold Medicine XL3 325 mg/1; 2 mg/1; 5 mg 63654-0605-20 Selder, 20 tablets — — FDA listed —
Allergy Multisymptom 325 mg/1; 2 mg/1; 5 mg 63868-0578-24 CHAIN 12 tablets — — FDA listed —
Allergy Sinus, Lil Drug Store 325 mg/1; 5 mg/1; 2 mg 66715-9927-03 Lil' 6 tablets — — FDA listed —
Allergy Multi Symptom 2 mg/1; 5 mg/1; 325 mg 68998-0228-02 MARC 12 tablets — — FDA listed —
Cold Medicine 325 mg/1; 2 mg/1; 5 mg 69168-0004-51 Allegiant 20 tablets — — FDA listed —
Allergy MultiSymptom 325 mg/1; 2 mg/1; 5 mg 72476-0128-02 RETAIL 12 tablets — — FDA listed —
Cold Medicine XL3 325 mg/1; 2 mg/1; 5 mg 76095-0011-20 Midway 20 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

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 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.

What it looks like

Color white
ShapeOval
ImprintFRH
Size17 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.

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

LabelerHaleon US Holdings LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00135
First marketedMar 2022
Product typeHuman Otc Drug
Portfolio405 products on file

More NDCs from Haleon US Holdings LLC labeler code 00135

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 55 words ▾

Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: sinus congestion and pressure runny nose and sneezing minor aches and pains nasal congestion headache temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus openings and passages

⏱️ Dosage and Administration 50 words ▾

Directions do not use more than directed adults and children 12 years of age and over: take 2 caplets every 4-6 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years of age: 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: blisters rash skin reddening 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 are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. 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 high blood pressure a breathing problem such as emphysema or chronic bronchitis heart disease liver disease thyroid disease glaucoma diabetes Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery drowsiness may occur Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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 9 words ▾

Other information store at controlled room temperature 20-25°C (68-77°F)

🧪 Active Ingredient 16 words ▾

Active ingredient (in each caplet) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 36 words ▾

Inactive ingredients benzyl alcohol, crospovidone, magnesium stearate, microcrystalline cellulose, modified corn starch, natural flavor, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, purified water, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

🎯 Purpose 7 words ▾

Purposes Pain reliever/Fever reducer Antihistamine Nasal decongestant

📄 Do Not Use 95 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 are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients

📄 Ask a Doctor Before Use If 38 words ▾

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

📄 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 38 words ▾

When using this product do not exceed recommended dosage excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery drowsiness may occur

📄 Stop Use and Ask a Doctor If 49 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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? 1-855-328-5259

📄 Package Label / Principal Display Panel 49 words ▾

Principal Display Panel NDC 0135-0578-03 FLONASE HEADACHE & ALLERGY RELIEF NEW INGREDIENTS Acetaminophen 325 mg Pain Reliever/Fever Reducer Chlorpheniramine Maleate 2 mg Antihistamine Phenylephrine HCI 5 mg Nasal Decongestant FAST RELIEF FROM Allergy Symptoms Headache Pain Nasal Congestion 96 CAPLETS B-0630-778-46 ORG – Front Carton B-0630-778-46 Flonase 96 Caplets

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 FLONASE Headache and Allergy Relief (this brand).

Top reported reactions

Fatigue3,318
Headache3,109
Dyspnoea2,925
Nausea2,918
Diarrhoea2,376
Pain2,342
Dizziness2,195

Reporter sex

49,313 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Hospitalization10,942
Death2,125
Disabling1,246
Life-threatening919
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,424 0
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

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 Haleon US Holdings 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 2 other package presentations of this same product, including 192 tablets (00135-0578-02), 768 tablets (00135-0578-03). 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?
Haleon US Holdings 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.
← 00135-0577-01 · Haleon 00135-0579-01 · Haleon →
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.