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Dawn Ultra Antibacterial Hand Apple Blossom Scent Chloroxylenol .3 g/100mL Soap, 458 mL — NDC 37000-0616-45 package photo

Dawn Ultra Antibacterial Hand Apple Blossom Scent Chloroxylenol .3 g/100mL Soap, 458 mL

by The Procter & Gamble Manufacturing Company · 458 mL in 1 BOTTLE, PLASTIC (37000-616-45)
NDC 37000-0616-45
🏷️ FDA NDC (as labeled) 37000-616-45 billing pads the product segment with a zero
This package
Contains458 mL Pack sizes23 compare ↓
Also comes in: 3 bottles 37000-0616-05 6 bottles 37000-0616-06 171 ml 37000-0616-17 192 ml 37000-0616-19 207 ml 37000-0616-20 221 ml 37000-0616-21 236 ml 37000-0616-23 434 ml 37000-0616-44 479 ml 37000-0616-47 532 ml 37000-0616-54 573 ml 37000-0616-57 638 ml 37000-0616-63 650 ml 37000-0616-65 709 ml 37000-0616-71 828 ml 37000-0616-82 910 ml 37000-0616-91 1120 ml 37000-0616-38 1200 ml 37000-0616-40 1660 ml 37000-0616-16 2070 ml 37000-0616-24 2210 ml 37000-0616-22 2660 ml 37000-0616-90
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 37000-616-45
Product NDC 37000-616
11-digit billing NDC 37000061645
UNII 0F32U78V2Q
UPC 0030772094006
Application # 505G(a)(3)
SPL Set ID 02def70d-345d-45db-92fe-4dddd12b2194
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-07-07
Marketing end 2027-05-01
Route TOPICAL
Dosage form SOAP
Substance CHLOROXYLENOL
Why two NDCs? The FDA registers this code as 37000-616-45 — 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 → 37000-0616-45. 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.

🏭 Manufacturer & labeler

LabelerThe Procter & Gamble Manufacturing Company
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code37000
First marketedJul 2014
Product typeHuman Otc Drug
Portfolio846 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.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter antibacterial hand soap containing chloroxylenol, a topical antimicrobial agent. Chloroxylenol is typically used in hand soaps to reduce bacteria on the skin during washing. The product is formulated as a liquid soap with an apple blossom scent and is applied to the hands and skin by washing. This soap is marketed under the FDA's over-the-counter monograph rules for antibacterial hand-cleansing products.

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.

🧪 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 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 80E6PSE1XL
    A synthetic surfactant derived from petroleum-based alcohols and ethylene oxide. It helps dissolve and distribute active ingredients evenly throughout the medicine, and may improve how the product spreads or absorbs.
  • UNII 8J6RDU8L9X
    A synthetic green dye used to color medications. It helps make pills and capsules visually distinct so patients can easily identify their medicine.
  • UNII 19FQ96EA8Q
    A synthetic compound made by combining fatty alcohol with polyethylene glycol units. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients together in the medicine.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII 4F6FC4MI8W
    Lauramine oxide is a surfactant, a substance that helps mix oil and water together. It's used in medicines to improve how ingredients blend and to help the product dissolve or spread properly.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII V86KZL3H2Z
    A silicone-based compound derived from propylene glycol polymers. It functions as an emulsifier and solvent in liquid formulations, helping to blend ingredients that don't naturally mix together.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 5EHL50I4MY
    A sodium salt compound used as a chelating agent in medicines. It binds to metals and minerals to improve stability, prevent discoloration, and help the medication stay effective longer.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesWater, sodium lauryl sulfate, lauramine oxide, alcohol denat., phenoxyethanol, tetrasodium glutamate diacetate, sodium chloride, deceth-8, fragrance, C9-11 alketh-8, PPG-26, sodium hydroxide, yellow 5, green 5

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.

💲 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: 3 bottles 6 bottles 171 ml 192 ml 207 ml 221 ml 236 ml 434 ml 479 ml 532 ml 573 ml 638 ml 650 ml 709 ml 828 ml 910 ml 1120 ml 1200 ml 1660 ml 2070 ml 2210 ml 2660 ml
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dawn Ultra Antibacterial Hand Apple Blossom Scent .3 g/100mLthis 37000-0616-45 The 458 ml — — FDA listed —
Kroger Antibacterial Green Apple Hand .3 g/100mL 73487-0001-01 Korex 709 ml — — Discontinued —
Dawn Ultra Antibacterial Hand Orange Scent .3 g/100mL 37000-0617-16 The 1660 ml — — Discontinued —
Super Suds Antibacterial Hand Item 1063 .3 g/100mL 50536-0163-01 AMERICAN 3785 ml — — FDA listed —
Radiance Antibacterial Green Apple Scent Hand .3 g/100mL 73487-0003-02 Korex 709 ml — — FDA listed —
E-2 Hand Item 1095 .3 g/100mL 50536-0195-01 AMERICAN 3785 ml — — FDA listed —
Simplify Antibacterial Hand Apple Blossom Scent .3 g/100mL 11822-0281-01 Rite 573 ml — — Discontinued —
Pearl Antimicrobial Hand Item 1027Ab-01 .3 g/100mL 50536-0127-01 AMERICAN 3785 ml — — FDA listed —
Soft Touch Plus Antibacterial Hand Item 1039 .3 g/100mL 50536-0139-01 AMERICAN 3785 ml — — FDA listed —
Radiance Antibacterial Citrus Scent Hand .3 g/100mL 73487-0004-02 Korex 709 ml — — Discontinued —
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

🏛️
2014
On the market since
Jul 2014
📍
2026
Currently FDA-listed
12 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
37000-0616-16 1660 mL in 1 BOTTLE, PLASTIC (37000-616-16) 2014-07-07 Discontinued by firm
37000-0616-19 192 mL in 1 BOTTLE, PLASTIC (37000-616-19) 2021-12-30 Discontinued by firm
37000-0616-20 207 mL in 1 BOTTLE, PLASTIC (37000-616-20) 2019-02-02 Discontinued by firm
37000-0616-21 221 mL in 1 BOTTLE, PLASTIC (37000-616-21) 2022-12-01 Active
37000-0616-22 2210 mL in 1 BOTTLE, PLASTIC (37000-616-22) 2017-02-10 Discontinued by firm
37000-0616-38 1120 mL in 1 BOTTLE, PLASTIC (37000-616-38) 2021-11-18 Active
37000-0616-40 1200 mL in 1 BOTTLE, PLASTIC (37000-616-40) 2019-02-02 Discontinued by firm
37000-0616-45 You're viewing this 458 mL in 1 BOTTLE, PLASTIC (37000-616-45) 2021-11-18 Active
37000-0616-47 479 mL in 1 BOTTLE, PLASTIC (37000-616-47) 2018-02-06 Discontinued by firm
37000-0616-57 573 mL in 1 BOTTLE, PLASTIC (37000-616-57) 2018-02-06 Discontinued by firm
37000-0616-63 638 mL in 1 BOTTLE, PLASTIC (37000-616-63) 2014-07-07 Active
37000-0616-71 709 mL in 1 BOTTLE, PLASTIC (37000-616-71) 2019-02-02 Discontinued by firm
37000-0616-82 828 mL in 1 BOTTLE, PLASTIC (37000-616-82) 2014-07-07 Active
37000-0616-90 2660 mL in 1 BOTTLE, PLASTIC (37000-616-90) 2014-07-07 Active
37000-0616-05 3 BOTTLE, PLASTIC in 1 CELLO PACK (37000-616-05) / 650 mL in 1 BOTTLE, PLASTIC 2023-02-07 Active
37000-0616-23 236 mL in 1 BOTTLE, PLASTIC (37000-616-23) 2017-02-10 Discontinued by firm
37000-0616-24 2070 mL in 1 BOTTLE, PLASTIC (37000-616-24) 2023-02-07 Active
37000-0616-44 434 mL in 1 BOTTLE, PLASTIC (37000-616-44) 2023-02-07 Active
37000-0616-54 532 mL in 1 BOTTLE, PLASTIC (37000-616-54) 2023-02-07 Active
37000-0616-65 650 mL in 1 BOTTLE, PLASTIC (37000-616-65) 2023-02-07 Active
37000-0616-06 6 BOTTLE, PLASTIC in 1 CELLO PACK (37000-616-06) / 650 mL in 1 BOTTLE, PLASTIC 2024-09-01 Active
37000-0616-17 171 mL in 1 BOTTLE, PLASTIC (37000-616-17) 2024-02-01 Active
37000-0616-91 910 mL in 1 BOTTLE, PLASTIC (37000-616-91) 2025-01-01 Active

Pack size FAQ

What quantity is in NDC 37000-0616-45?
NDC 37000-0616-45 contains 458 mL — 458 ml in 1 bottle, plastic.
What is the difference between NDC 37000-0616-45 and NDC 37000-0616-17?
Both are Dawn Ultra Antibacterial Hand Apple Blossom Scent Chloroxylenol .3 g/100mL Soap — the drug itself is identical. NDC 37000-0616-45 is the 458 mL package, while NDC 37000-0616-17 is the 171 ml package.
What NDC number is used to bill for this package of Dawn Ultra Antibacterial Hand Apple Blossom Scent Chloroxylenol .3 g/100mL Soap?
Bill NDC 37000-0616-45 — the 11-digit billing format is 37000061645. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 37000-616-45, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 37000-0616-45, written without dashes as 37000061645. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 37000-0616-45, the first segment (37000) is the labeler code FDA assigned to The Procter & Gamble Manufacturing Company; the middle segment (0616) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (45) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page it is currently marketed — but The Procter & Gamble Manufacturing Company has reported a marketing end date of 2027-05-01, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 22 other package presentations of this same product, including 3 bottles (37000-0616-05), 6 bottles (37000-0616-06), 171 ml (37000-0616-17). 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?
The Procter & Gamble Manufacturing Company 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.

📄 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 9 words ▾

Use for handwashing to decrease bacteria on the skin

⏱️ Dosage and Administration 21 words ▾

Directions wet hands and forearms. Apply 5 ml or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.

⚠️ Warnings 31 words ▾

Warnings For external use only Keep out of reach of children. In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.

🧪 Active Ingredient 4 words ▾

Active ingredient Chloroxylenol 0.30%

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients Water, sodium lauryl sulfate, lauramine oxide, alcohol denat., phenoxyethanol, tetrasodium glutamate diacetate, sodium chloride, deceth-8, fragrance, C9-11 alketh-8, PPG-26, sodium hydroxide, yellow 5, green 5

🎯 Purpose 4 words ▾

Purpose Antibacterial hand soap

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 37000-0603-40 · The 37000-0617-16 · The →
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.