Home › NDC Lookup › Ingredients › Phenylephrine Hcl › 37808-0453-23
Nasal Decongestant PE Phenylephrine HCl 10 mg Tablet, Film Coated — NDC 37808-0453-23 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nasal Decongestant PE Phenylephrine HCl 10 mg Tablet, Film Coated — NDC 37808-453-23 (Billing 37808-0453-23)

by H E B · 3 BLISTER PACK in 1 CARTON / 24 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Nasal Decongestant PE Phenylephrine HCl 10 mg Tablet, Film Coated from H E B, marketed since Jan 2005 and currently FDA-listed. It is this product's only package size.

NDC 37808-0453-23
🏷️ FDA NDC (as labeled) 37808-453-23 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 37808-453-23
Product NDC 37808-453
11-digit billing NDC 37808045323
RxCUI 1049182
UNII 04JA59TNSJ
UPC 0041220360079
Application # M012
SPL Set ID 7c04ab14-af28-4598-90ef-56ac11902c7d
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-01-14
Route ORAL
Dosage form TABLET, FILM COATED
Substance PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1049182
Why two NDCs? The FDA registers this code as 37808-453-23 — 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 → 37808-0453-23. 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 alpha-1 Adrenergic Agonist class.

Pharmacologic class alpha-1 Adrenergic Agonist
Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use
How it works Adrenergic alpha1-Agonists
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 it is MedlinePlus · NLM

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. The injection raises low blood pressure during anesthesia and, for some products, septic shock. Eye drops dilate the pupil, nasal products relieve conges...
  • Be careful. Over-the-counter phenylephrine should not be used with a prescription MAOI or within 2 weeks of stopping one. If you aren't sure whether your medicine is an MAOI, ask m...
  • With the injection, the most common are nausea, vomiting and headache. Call for help right away if you have chest pain, a very slow heartbeat, or pain or skin changes around the IV...
  • Stop and talk to a doctor if you get nervousness, dizziness or sleeplessness. Also stop if symptoms last more than 7 days or come with a fever. Don't use more than the label recomm...
📖 Read our full Phenylephrine guide →

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.
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
37808-0453-23 You're viewing this Main listing 3 BLISTER PACK in 1 CARTON / 24 TABLET, FILM COATED in 1 BLISTER PACK 2005-01-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nasal Decongestant PE Maximum Strength 10 mg 70677-1152-01 Strategic 18 tablets $0.050 — Availability likely —
Nasal Decongestant PE 10 mg 00363-4531-07 Walgreen 18 tablets — — FDA listed —
PhysiciansCare Sinus Non-Drowsy 10 mg 00924-0133-01 Acme 1 tablet — — FDA listed —
Sinus Pressure and Congestion Relief PE Maximum Strength 10 mg 11822-4530-02 Rite 24 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 21130-0453-07 Better 18 tablets — — FDA listed —
Sinus Decongestion PE 10 mg 30142-0534-07 Kroger 18 tablets — — FDA listed —
Sinus Congestion 10 mg 30142-0853-07 Kroger 18 tablets — — FDA listed —
PE Sinus Congestion 10 mg 36800-0704-07 Topco 18 tablets — — FDA listed —
Nasal Decongestant PE 10 mgthis 37808-0453-23 H 24 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 37835-0651-01 Bi-Mart 100 tablets — — FDA listed —
Medi-First Sinus Decongestant 10 mg 47682-0809-13 Unifirst 1 tablet — — FDA listed —
Medi-First Plus Sinus Decongestant 10 mg 47682-0990-33 Unifirst 1 tablet — — FDA listed —
Unishield Sinus Decongestant 10 mg 49314-2083-03 Unishield 1 tablet — — FDA listed —
Pseudo Time Pe 10 mg 49483-0234-00 TIME 100000 tablets — — FDA listed —
Good Sense Nasal Decongestant PE 10 mg 50090-3659-00 A-S 36 tablets — — FDA listed —
Phenylephrine HCl Maximum Strength 10 mg 50090-5606-00 A-S 18 tablets — — FDA listed —
Nasal Decongestant Pe 10 mg 50090-7449-00 A-S 18 tablets — — FDA listed —
Sudafed PE Sinus Congestion 10 mg 50580-0437-01 Kenvue 18 tablets — — FDA listed —
Sinus Congestion 10 mg 50844-0493-08 L.N.K. 24 tablets — — FDA listed —
Suphedrine PE Sinus Congestion Non-Drowsy 10 mg 55301-0753-23 ARMY 24 tablets — — FDA listed —
SU PHEDRINE PE Non-Drowsy, Maximum Strength 10 mg 57243-0453-44 Salado 18 tablets — — FDA listed —
Su Phedrine Pe Sinus Congestion 10 mg 57243-0953-44 Salado 18 tablets — — FDA listed —
Phenylephrine Hydrochloride 10 mg 57631-0018-00 InvaTech 30000 tablets — — FDA listed —
Nasal Decongestant PE Non-Drowsy Maximum Strength 10 mg 63868-0144-19 CHAIN 18 tablets — — FDA listed —
Nasal Decongestant PE Maximum Strength 10 mg 67091-0207-18 WinCo 18 tablets — — FDA listed —
Nasal Decongestant PE Maximum Strength Non-Drowsy 10 mg 69168-0272-17 Allegiant 300 tablets — — FDA listed —
Redicare Nasal and Sinus Decongestant 10 mg 71105-0272-02 Redicare 100 tablets — — FDA listed —
Gencare-Nasal Decongestant PE 10 mg 72090-0025-01 Pioneer 300 tablets — — FDA listed —
Gencare-Nasal Decongestant PE 10 mg 72090-0039-01 Pioneer 300 tablets — — FDA listed —
Crane Safety Sinus Decongestant 10 mg 73408-0990-33 Crane 1 tablet — — FDA listed —
ValuMeds Nasal Decongestant Phenylephrine HCl 10 mg 82725-1111-01 Cabinet 300 tablets — — FDA listed —
Goodmeds Non-Drowsy Nasal Decongestant PE 10 mg 82725-4111-01 Cabinet 365 tablets — — FDA listed —
Sinus Congestion 10 mg 83324-0073-18 Chain 18 tablets — — FDA listed —
Phenylephrine Hydrochloride 10 mg 83586-0010-00 HHH 130000 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 83586-0160-01 HHH 100 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 84324-0010-01 NUVICARE 100 tablets — — FDA listed —
Nasal Decongestant PE Maximum Strength 10 mg 85766-0178-18 Sportpharm 18 tablets — — FDA listed —
Medi-First Plus Sinus Decongestant 10 mg 85766-0182-01 Sportpharm 1 tablet — — 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

🏛️
2005
On the market since
Jan 2005
📍
2026
Currently FDA-listed
21 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 red
ShapeRound
Imprint44;453
Size7 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 K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII LX22YL083G
    A simple sugar derived from corn or other sources. It acts as a filler to give the medicine bulk and volume, and as a sweetener to improve taste in oral medications.
  • UNII O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.
  • UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.

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

The official label also statescroscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, 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

LabelerH E B
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code37808
First marketedJan 2005
Product typeHuman Otc Drug
Portfolio264 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 📄 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 23 words ▾

Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure

⏱️ Dosage and Administration 31 words ▾

Directions adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: ask a doctor

⚠️ Warnings 145 words ▾

Warnings Do not use 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. Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland When using this product do not exceed recommended dosage.

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever 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 36 words ▾

Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

🧪 Active Ingredient 9 words ▾

Active ingredient (in each tablet) Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

🎯 Purpose 3 words ▾

Purpose Nasal decongestant

📄 Do Not Use 55 words ▾

Do not use 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.

📄 Ask a Doctor Before Use If 26 words ▾

Ask a doctor before use if you have heart disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland

📄 When Using This Product 9 words ▾

When using this product do not exceed recommended dosage.

📄 Stop Use and Ask a Doctor If 23 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-426-9391

📄 Package Label / Principal Display Panel 127 words ▾

Principal Display Panel Compare to Sudafed PE® Congestion active ingredient* NDC 37808-453-23 H-E-B® Maximum Strength Nasal Decongestant PE Phenylephrine HCl 10 mg / Nasal Decongestant Sinus Decongestant Non-Drowsy Relief of: • Congestion • Sinus Pressure actual size 72 TABLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Sudafed PE® Sinus Congestion.

50844 REV0820B45323 MADE WITH PRIDE AND CARE FOR H-E-B® SAN ANTONIO, TX 78204 H-E-B® 100% GUARANTEE promise If you aren't completely pleased with this product, we'll be happy to replace it or refund your money. You have our word on it. HEB 44-453 HEB 44-453

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Phenylephrine HCl (matched by generic name) — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Phenylephrine HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.7K
Claims incl. refills
148
Beneficiaries
134
Spend / beneficiary
$27.89
Spend / claim
$25.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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 NASAL DECONGESTANT PE (this brand).

Top reported reactions

Pain1,217
Pemphigus1,056
Joint Swelling1,035
Rheumatoid Arthritis989
Infusion Related Reaction968
Systemic Lupus Erythematosus965
Injury962

Age at onset

Neonate41
Infant13
Child4
Adolescent5
Adult569
Elderly95

Reporter sex

4,316 reports
Male · 19%
Female · 80%
Unknown · 0%

Serious outcomes

Hospitalization2,322
Death1,930
Life-threatening1,874
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,008 95
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) ✓ 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 H E B. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
H E B 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.
← 37808-0449-34 · H 37808-0457-52 · H →
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.