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Rugby Chest Congestion Relief DM Dextromethorphan Hydrobromide / Guaifenesin 20 mg; 400 mg Tablet, 60-count — NDC 00536-1312-08 package photo

Rugby Chest Congestion Relief DM Dextromethorphan Hydrobromide / Guaifenesin 20 mg; 400 mg Tablet, 60-count

by Rugby Laboratories · 60 TABLET in 1 BOTTLE (0536-1312-08)
NDC 00536-1312-08
🏷️ FDA NDC (as labeled) 0536-1312-08 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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) 0536-1312-08
Product NDC 0536-1312
11-digit billing NDC 00536131208
NCPDP billing unit EA — each (per item)
RxCUI 1147685
UNII 9D2RTI9KYH, 495W7451VQ
Application # M012
SPL Set ID 5da36516-9f94-49cb-9421-0c310abcd116
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-01
Route ORAL
Dosage form TABLET
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
GPI-14 43997002520345
GPI class Chest Congestion Relief DM
GCN Seq No 058386
GCN 23807
HICL code 000223
Ingredient (HICL) Guaifenesin/Dextromethorphan
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 B3T
Therapeutic class — specific (HIC3) Non-Opioid Antitussive And Expectorant Combination
AHFS code 48:08.00.00
AHFS class Antitussives
FDB label name CHEST CONG RLF DM 400-20 MG TB
FDB brand name Chest Congestion Relief Dm
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1312-08 — 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 → 00536-1312-08. 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 Uncompetitive N-methyl-D-aspartate Receptor Antagonist class.

Pharmacologic class Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Sigma-1 Agonist
Drug family (ATC) Other antidepressants, Opium alkaloids and derivatives
How it works Uncompetitive NMDA Receptor Antagonists, Sigma-1 Receptor 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.

🏭 Manufacturer & labeler

LabelerRugby Laboratories
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedSep 2020
Product typeHuman Otc Drug
Portfolio149 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

Label name CHEST CONG RLF DM 400-20 MG TB Ingredient Guaifenesin/Dextromethorphan
📖 What it is MedlinePlus · NLM

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • The two ingredients tackle your symptoms from different angles. Guaifenesin is an expectorant — it helps thin and loosen the mucus in your chest so you can cough it up more easily....
  • What exactly does this combination do — why are two ingredients needed?
  • It depends on which antidepressant you're taking. If it's a type called an MAOI — which includes certain older antidepressants and some medications for Parkinson's disease — you sh...
  • Can I take this if I'm on an antidepressant?
📖 Read our full Dextromethorphan / Guaifenesin 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.

💊 What it looks like

Color white
ShapeOval
ImprintPH073
Size17 mm
ScoringScored — splits in 2
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 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 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 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also statesInactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

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 eaPer package
Retail pharmacies payNADAC · weekly $0.080 $4.77 / 60 tablets
Medicaid paysCMS SDUD · 12 mo $0.3055 $18.33 / 60 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.083 $0.072
▲ Up 7% over the last 24 months.
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
Quality Choice Mucus Relief DM DM 20 mg/1; 400 mg 63868-0753-50 Chain 50 tablets $0.074 — FDA listed save 7%
Rugby Chest Congestion Relief DM 20 mg/1; 400 mgthis 00536-1312-08 Rugby 60 tablets $0.079 — Availability likely —
Good Neighbor Pharmacy Mucus Relief DM 20 mg/1; 400 mg 24385-0026-71 AmerisourceBergen 50 tablets $0.079 — Availability likely —
Mucus Relief DM Cough 20 mg/1; 400 mg 46122-0790-61 Amerisource 50 tablets $0.079 — Availability likely —
Leader Chest Congestion Relief DM 20 mg/1; 400 mg 70000-0056-01 Cardinal 60 tablets $0.079 — Availability likely —
Mucus Relief DM Cough Maximum Strength 20 mg/1; 400 mg 70000-0278-01 Cardinal 12 tablets $0.079 — Availability likely —
Foster and Thrive Chest Congestion Relief DM DM 20 mg/1; 400 mg 70677-1055-01 Strategic 50 tablets $0.079 — Availability likely —
Quality Choice Mucus Relief DM DM 20 mg/1; 400 mg 83324-0195-50 Chain 50 tablets $0.079 — Availability likely —
Sunmark Chest Congestion Relief DM DM 20 mg/1; 400 mg 49348-0728-09 Strategic 50 tablets $0.080 — Availability likely +0%
Mucus Relief DM 20 mg/1; 400 mg 00363-0533-01 Walgreen 30 tablets — — FDA listed —
Refenesen Mucus Relief DM 20 mg/1; 400 mg 10956-0846-30 Reese 30 tablets — — FDA listed —
Pharbinex-Dm 400 mg/1; 20 mg 16103-0381-04 Pharbest 30 tablets — — FDA listed —
Mucus Relief Cough and Congestion DM 20 mg/1; 400 mg 17714-0150-60 Advance 60 tablets — — FDA listed —
Kroger Chest Congestion Relief DM 20 mg/1; 400 mg 30142-0472-30 THE 30 tablets — — FDA listed —
TopCare Chest Congestion and Cough Relief DM 20 mg/1; 400 mg 36800-0988-50 TOPCO 30 tablets — — FDA listed —
Mucus Relief Dm 20 mg/1; 400 mg 37835-0403-40 Bi-Mart 40 tablets — — FDA listed —
Equaline Chest Congestion Relief DM DM 20 mg/1; 400 mg 41163-0114-50 United 50 tablets — — FDA listed —
Mucus Relief Dm 20 mg/1; 400 mg 41226-0280-03 KROGER 30 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 41250-0533-11 Meijer 60 tablets — — FDA listed —
Guaifenesin DM 400 mg/1; 20 mg 43063-0801-60 PD-Rx 60 tablets — — FDA listed —
Medique Medi-Mucus 20 mg/1; 400 mg 47682-0432-46 Unifirst 1 tablet — — FDA listed —
Mucosa Dm 400 mg/1; 20 mg 49483-0280-00 TIME 100000 tablets — — FDA listed —
Mucus Relief DM Immediate Release 20 mg/1; 400 mg 50804-0432-30 Good 30 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 50804-0858-30 Good 30 tablets — — Discontinued —
Mucus Relief DM Cough 20 mg/1; 400 mg 50844-0633-11 L.N.K. 60 tablets — — FDA listed —
Mucosa DM 20 mg/1; 400 mg 54257-0277-01 Magno-Humphries, 50 tablets — — FDA listed —
Mucus Relief Cough and Congestion DM 20 mg/1; 400 mg 54738-0985-30 Richmond 30 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 55301-0533-01 ARMY 10 tablets — — FDA listed —
Family Wellness Chest Congestion Relief DM DM 20 mg/1; 400 mg 55319-0890-30 Family 30 tablets — — FDA listed —
Dollar General Chest Congestion Relief DM 20 mg/1; 400 mg 55910-0272-30 Dolgencorp, 30 tablets — — FDA listed —
Chest Congestion Relief DM 20 mg/1; 400 mg 55910-0533-01 DOLGENCORP, 30 tablets — — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide 400 mg/1; 20 mg 57631-0013-10 InvaTech 26500 tablets — — FDA listed —
Mucus Relief Xpect 400 mg/1; 20 mg 63654-0342-20 Selder, 20 tablets — — FDA listed —
Always Save Chest Congestion Relief DM 20 mg/1; 400 mg 63941-0985-50 Valu 50 tablets — — FDA listed —
Marcs Chest Congestion Relief DM 20 mg/1; 400 mg 68998-0114-50 Marc 50 tablets — — FDA listed —
Mucus Relief DM Immediate Release 20 mg/1; 400 mg 69168-0432-07 Allegiant 10 tablets — — FDA listed —
CVS Chest Congestion Relief DM 20 mg/1; 400 mg 69842-0996-30 CVS 30 tablets — — FDA listed —
RIGHT REMEDIES Mucus Relief DM 20 mg/1; 400 mg 70692-0181-25 Strive 250 tablets — — FDA listed —
Mucus Relief Cough and Congestion DM 20 mg/1; 400 mg 71335-1928-01 Bryant 30 tablets — — FDA listed —
Rugby Chest Congestion Relief DM 20 mg/1; 400 mg 71335-2216-01 Bryant 30 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 72090-0027-01 Pioneer 150 tablets — — FDA listed —
Care One Chest Congestion Relief DM 20 mg/1; 400 mg 72476-0871-50 RETAIL 50 tablets — — FDA listed —
Pharbinex-DM 400 mg/1; 20 mg 73057-0381-04 Ulai 30 tablets — — FDA listed —
Mucus Relief Xpect 400 mg/1; 20 mg 76095-0012-20 Midway 20 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 76162-0008-01 TopCo 100 tablets — — FDA listed —
Mucus DM 20 mg/1; 400 mg 79481-5330-01 Meijer 60 tablets — — FDA listed —
Mucus Relief Dm 20 mg/1; 400 mg 80513-0407-09 Advanced 90 tablets — — FDA listed —
Mucus Relief DM 20 mg/1; 400 mg 84324-0035-01 NUVICARE 100 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

🏛️
2020
On the market since
Sep 2020
📍
2026
Currently FDA-listed
6 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00536-1312-08, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.4K
Units reimbursed last 4 qtrs
119.7K
Gross reimbursed last 4 qtrs
$36.6K
Avg / prescription
$10.92
Avg / unit
$0.3055
Latest quarter Q4 2025
919Rx
Medicaid pays / ea
$0.3055
gross reimbursed
vs
NADAC / ea
$0.0795
acquisition cost
=
Spread
+$0.2260
+284% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
82% FFS 18% MCO
Fee-for-service · 2,751 Rx Managed care · 599 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 60,171 units · 307 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 3,955 units · 33.6 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 10,719 units · 115 per 100k residents NJ Massachusetts: no data reported MA California: 38,549 units · 98.9 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 926 units · 20.5 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 2,278 units · 36.9 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 3,135 units · 42.2 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
20.5307
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 307 /100k
2 New Jersey 115 /100k
3 California 98.9 /100k
4 Arizona 42.2 /100k
5 Maryland 36.9 /100k
6 Ohio 33.6 /100k
7 Kentucky 20.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00536-1312-08 You're viewing this 60 TABLET in 1 BOTTLE (0536-1312-08) 2020-09-01 Active

📄 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
🎯 Indications and Usage 42 words ▾

Uses ■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold ■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ■ Helps make coughs more productive.

⏱️ Dosage and Administration 64 words ▾

Directions ■ Adults and children 12 years of age and over : take 1 tablet every 4 hours as needed. ■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed. ■ Children under 6 years of age: consult a doctor. Do not exceed 6 doses in a 24 hour period or as directed by a doctor

⚠️ Warnings 54 words ▾

Warnings Do not use ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.

📦 Storage and Handling 6 words ▾

Other Information Store at 15°-30°C (59°-86°F)

🧪 Active Ingredient 10 words ▾

Active ingredient - (per tablet) Dextromethorphan Hydrobromide 20mg Guaifenesin 400mg

🧪 Inactive Ingredients 25 words ▾

Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid. image of display

🎯 Purpose 4 words ▾

Purpose Cough Suppressant Expectorant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00536-1311-08 · Rugby 00536-1313-85 · RUGBY →
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.