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GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN 100 mg/5mL; 10 mg/5mL Syrup — NDC 00121-0638-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN 100 mg/5mL; 10 mg/5mL Syrup — NDC 0121-0638-00 (Billing 00121-0638-00)

by PAI Holdings, LLC dba PAI Pharma · 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE

This is a package of GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN 100 mg/5mL; 10 mg/5mL Syrup from PAI Holdings, LLC dba PAI Pharma, marketed since Jul 1992 and currently FDA-listed. It is the main listing for this product, which comes in 4 package sizes.

NDC 00121-0638-00
🏷️ FDA NDC (as labeled) 0121-0638-00 billing pads the labeler segment with a zero
This package
Contains5 mL in 1 cup, unit-dose Medicaid pays$0.9554 / unit · 12 mo Per package$477.70 / 500 ml · Medicaid Pack sizes4 compare ↓
Main listing for product 0121-0638 · Also comes in: 118 ml 0121-0638-04 237 ml 0121-0638-08 473 ml 0121-0638-16
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 0121-0638-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0121 labeler · 0638 product · 00 package
Package marketed since
Jul 1, 1992
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0301210638046, 0301210638169
Medicaid fills, this package
220 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0121-0638-00
Product NDC 0121-0638
11-digit billing NDC 00121063800
NCPDP billing unit ML — per mL (volume)
RxCUI 996520
UNII 495W7451VQ, 7355X3ROTS
UPC 0301210638046, 0301210638169
Application # M012
SPL Set ID ff970fff-d1a3-4322-83b4-34e361431a1c
Established class (EPC) Expectorant; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Sigma-1 Agonist
Mechanism of action Uncompetitive NMDA Receptor Antagonists; Sigma-1 Receptor Agonists
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 1992-07-01
Route ORAL
Dosage form SYRUP
Substance GUAIFENESIN; DEXTROMETHORPHAN

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

GPI-14 43997002521220
GPI class guaiFENesin-DM
GCN Seq No 016414
GCN 53495
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 GUAIFENESIN-DM 100-10 MG/5 ML
FDB brand name Guaifenesin-Dextromethorphan
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 016414
  • GCN: 53495
  • GPI-14 (Medi-Span): 43997002521220
  • HICL (First Databank): 000223
  • AHFS class code: 48:08.00.00
  • RxCUI (RxNorm): 996520
Why two NDCs? The FDA registers this code as 0121-0638-00 — 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 → 00121-0638-00. 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.

Clinical

Label name GUAIFENESIN-DM 100-10 MG/5 ML 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
  • It helps loosen mucus and makes coughs more productive. It also temporarily eases cough from minor throat and bronchial irritation, like with a cold or inhaled irritants.
  • Swallow them whole with a full glass of water. Don’t crush, chew or break them. You can take them with or without food, about every 12 hours as your label directs.
  • How do I take the extended-release tablets?
  • The extended-release tablets are not for children under 12. Some liquid products are made for children, so check that product’s label and ask me if you’re unsure.
📖 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.

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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.9554 $477.70 / 500 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
00121-0638-00 You're viewing this Main listing 10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE 1992-07-01 — Active
00121-0638-04 0121-0638-04 118 mL in 1 BOTTLE 1992-07-01 — Active
00121-0638-08 0121-0638-08 237 mL in 1 BOTTLE 1992-07-01 — Active
00121-0638-16 0121-0638-16 473 mL in 1 BOTTLE 1992-07-01 — Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose.
What NDC number is used to bill for this package of GUAIFENESIN DM GUAIFENESIN and DEXTROMETHORPHAN 100 mg/5mL; 10 mg/5mL Syrup?
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
Chest Congestion Relief DM 10 mg/5mL; 100 mg/5mL 00536-1313-85 RUGBY 473 ml $0.009 — Availability likely —
Tusnel Diabetic 10 mg/5mL; 100 mg/5mL 54859-0505-04 LLORENS 118 ml $0.011 — Availability likely —
Mucolyte DM 100 mg/5mL; 10 mg/5mL 57237-0360-12 Rising 118 ml $0.011 — Availability likely —
Tussin DM Regular 20 mg/10mL; 200 mg/10mL 82568-0014-04 AARNA 1 bottle $0.011 — Availability likely —
Tussin DM Sugar free 20 mg/10mL; 200 mg/10mL 82568-0015-04 AARNA 1 bottle $0.011 — Availability likely —
Tussin DM Cough and Chest Congestion Non Drowsy 20 mg/10mL; 200 mg/10mL 63868-0868-54 QUALITY 1 bottle $0.018 — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 58657-0504-08 Method 237 ml $0.024 — Availability likely —
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 58657-0505-08 Method 237 ml $0.024 — Availability likely —
Dextromethorphan HBr. and Guaifenesin 10 mg/5mL; 100 mg/5mL 57237-0312-51 Rising 100 cups $0.405 — Availability likely —
Dextromethorphan HBr and Guaifenesin Oral Solution 100 mg/5mL; 10 mg/5mL 81033-0103-50 KESIN 100 cups $0.405 — Availability likely —
Guaifenesin Dm 100 mg/5mL; 10 mg/5mLthis 00121-0638-00 PAI 10 cups — — FDA listed —
Guaifenesin Dm 200 mg/10mL; 20 mg/10mL 00121-1276-00 PAI 10 cups — — FDA listed —
Guaifenesin and Dextromethorphan 100 mg/5mL; 10 mg/5mL 00904-7512-70 Major 10 cups — — FDA listed —
Guaifenesin and Dextromethorphan 200 mg/10mL; 20 mg/10mL 00904-7513-72 Major 10 cups — — FDA listed —
Carolina Crud Crusher 200 mg/10mL; 20 mg/10mL 11383-0311-08 Weeks 236 ml — — FDA listed —
Target Cough plus Chest Congestion DM Max with Honey 20 mg/20mL; 400 mg/20mL 11673-0775-08 TARGET 1 bottle — — FDA listed —
MAX Tussin Cough and Chest Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 17856-1126-01 ATLANTIC 72 cups — — FDA listed —
Adult Cough and Chest Congestion Relief DM Non Drowsy 20 mg/10mL; 200 mg/10mL 21130-0385-04 Safeway, 1 bottle — — FDA listed —
Tussin DM Cough and Chest Congestion 20 mg/10mL; 200 mg/10mL 21130-0583-04 Safeway, 1 bottle — — FDA listed —
Tussin Cough Sugar Free 20 mg/10mL; 200 mg/10mL 49580-0834-04 P 1 bottle — — FDA listed —
Tukol Sugar Free Cough and Cold 2 mg/mL; 20 mg/mL 50066-0505-04 Genomma 1 bottle — — FDA listed —
Sorbugen 15 mg/7.5mL; 150 mg/7.5mL 52083-0660-16 Kramer 480 ml — — FDA listed —
Defensol Adult Syrup 200 mg/10mL; 20 mg/10mL 53145-0039-04 Menper 1 bottle — — FDA listed —
Cosedal Drops 10 mg/5mL; 100 mg/5mL 53145-0059-02 Menper 1 bottle — — FDA listed —
Adult Bisolvine Adult 20 mg/10mL; 200 mg/10mL 53145-0323-04 MENPER 120 ml — — FDA listed —
Altituss 15 mg/7.5mL; 150 mg/7.5mL 53163-0113-16 Alternative 473 ml — — FDA listed —
Tussin DM Cough and Chest Congestion 10 mg/5mL; 100 mg/5mL 53942-0503-26 DeMoulas 237 ml — — FDA listed —
Tussin DM 10 mg/5mL; 100 mg/5mL 53943-0503-26 Discount 237 ml — — FDA listed —
Limpia Pecho 10 mg/5mL; 100 mg/5mL 54859-0011-04 Llorens 118 ml — — FDA listed —
Tusnel SF 10 mg/5mL; 100 mg/5mL 54859-0506-04 Llorens 118 ml — — FDA listed —
Tusnel Cough Suppressant Expectorant 10 mg/5mL; 100 mg/5mL 54859-0509-16 Llorens 473 ml — — FDA listed —
Llorens Care Tussin DM 10 mg/5mL; 100 mg/5mL 54859-0833-04 Llorens 118 ml — — FDA listed —
Guaifenesin Dm 100 mg/5mL; 10 mg/5mL 55154-5783-05 Cardinal 5 cups — — FDA listed —
Guaifenesin Dm 100 mg/5mL; 10 mg/5mL 55154-5785-05 Cardinal 5 cups — — FDA listed —
Dextromethorphan HBr. and Guaifenesin 20 mg/10mL; 200 mg/10mL 57237-0313-18 Rising 80 cups — — FDA listed —
Tussin Cough Expectorant Cough Supressant Dm 10 mg/5mL; 100 mg/5mL 57243-0503-24 Salado 118 ml — — FDA listed —
Geri-Tussin DM 20 mg/10mL; 200 mg/10mL 57896-0291-16 Geri-Care 473 ml — — FDA listed —
Geri-Tussin DM 10 mg/5mL; 100 mg/5mL 57896-0661-08 Geri-Care 237 ml — — FDA listed —
Guaiasorb DM 10 mg/5mL; 100 mg/5mL 57896-0736-04 Geri-Care 118 ml — — FDA listed —
Guaiasorb Dm 20 mg/10mL; 200 mg/10mL 57896-0739-04 Geri-Care 118 ml — — FDA listed —
Giltuss HBP Cough and Chest Congestion 20 mg/10mL; 200 mg/10mL 58552-0132-04 Gil 1 bottle — — FDA listed —
Giltuss Childrens Cough and Chest Congestion 10 mg/5mL; 100 mg/5mL 58552-0133-04 Gil 1 bottle — — FDA listed —
Giltuss Diabetic Cough and Cold 200 mg/10mL; 20 mg/10mL 58552-0134-04 Gil 1 bottle — — FDA listed —
Giltuss Honey Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 58552-0140-04 Gil 1 bottle — — FDA listed —
Childrens Giltuss Honey Cough and Chest Congestion 100 mg/5mL; 10 mg/5mL 58552-0141-04 Gil 1 bottle — — FDA listed —
Rompe Pecho DM 10 mg/5mL; 100 mg/5mL 58593-0275-04 Efficient 118 ml — — Discontinued —
Rompe Pechito DM for Kids 5 mg/2.5mL; 50 mg/2.5mL 58593-0276-04 Efficient 118 ml — — FDA listed —
Guaifenesin DM 100 mg/5mL; 10 mg/5mL 60687-0817-17 American 10 cups — — FDA listed —
Guaifenesin DM 200 mg/10mL; 20 mg/10mL 60687-0828-56 American 10 cups — — FDA listed —
ACTINEL Diabetic 10 mg/5mL; 100 mg/5mL 63102-0140-16 ACTIPHARMA, 473 ml — — FDA listed —
Tussin Cough DM Sugar Free 20 mg/10mL; 200 mg/10mL 63868-0869-04 QUALITY 1 bottle — — FDA listed —
Cough and Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 63941-0817-04 Best 1 bottle — — FDA listed —
Childrens Giltuss Honey Cough and Chest Congestion 10 mg/5mL; 100 mg/5mL 65852-0003-04 Dextrum 1 bottle — — FDA listed —
Giltuss Honey Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 65852-0005-04 Dextrum 1 bottle — — FDA listed —
Giltuss HBP Cough and Chest Congestion 200 mg/10mL; 20 mg/10mL 65852-0006-04 Dextrum 1 bottle — — FDA listed —
Giltuss Diabetic 20 mg/10mL; 200 mg/10mL 65852-0009-04 Dextrum 1 bottle — — FDA listed —
Giltuss Childrens Cough and Chest Congestion 100 mg/5mL; 10 mg/5mL 65852-0019-04 Dextrum 1 bottle — — FDA listed —
SDA Laboratories Tussin DM 10 mg/5mL; 100 mg/5mL 66424-0565-16 SDA 473 ml — — FDA listed —
Adult Tussin DM Lil Drug Store Products 10 mg/5mL; 100 mg/5mL 66715-6858-04 Lil' 1 bottle — — FDA listed —
Tussin DM Cough and Chest Non Drowsy 20 mg/10mL; 200 mg/10mL 67091-0265-18 WinCo 1 bottle — — FDA listed —
Tussin DM Cough and Chest 20 mg/10mL; 200 mg/10mL 67091-0469-04 WinCo 1 bottle — — FDA listed —
Guaiasorb DM 10 mg/5mL; 100 mg/5mL 68071-3938-04 NuCare 118 ml — — FDA listed —
Sorbutuss NR 10 mg/5mL; 100 mg/5mL 68436-0120-16 Dextrum 474 ml — — FDA listed —
Tussin DM 10 mg/5mL; 100 mg/5mL 69168-0477-66 Allegiant 1 bottle — — FDA listed —
Tussin Cough and Chest Congestion DM adult 20 mg/10mL; 200 mg/10mL 69256-0385-08 Harris 1 bottle — — FDA listed —
Guaifenesin Syrup and Dextromethorphan 100 mg/5mL; 10 mg/5mL 69339-0149-19 Natco 10 cups — — FDA listed —
Guaifenesin Syrup and Dextromethorphan 100 mg/5mL; 10 mg/5mL 69339-0150-19 Natco 10 cups — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0035-04 OPMX 118 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0036-04 OPMX 118 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0069-04 OPMX 118 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 69729-0812-04 OPMX 118 ml — — FDA listed —
Akin Cough Formula DM 10 mg/5mL; 100 mg/5mL 69822-0202-04 Southern 118 ml — — FDA listed —
MAX Tussin Cough and Chest Congestion DM 20 mg/10mL; 200 mg/10mL 71399-0025-04 Akron 1 bottle — — FDA listed —
MAX Tussin Cough and Chest Congestion DM Sugar Free 20 mg/10mL; 200 mg/10mL 71399-0026-04 Akron 1 bottle — — FDA listed —
Guaifenesin DM 10 mg/5mL; 100 mg/5mL 71800-0057-05 Innovida 119 ml — — FDA listed —
Guaifenesin and Dextromethorphan Hydrobromide 10 mg/5mL; 100 mg/5mL 72162-2277-02 Bryant 237 ml — — FDA listed —
Guaifed DM 200 mg/10mL; 20 mg/10mL 73564-0802-04 Aldama 118 ml — — FDA listed —
Tussin Cough Expectorant Cough Supressant Dm 10 mg/5mL; 100 mg/5mL 76281-0503-24 AptaPharma 118 ml — — FDA listed —
Revasol Tussin DM Cough Suppressant Expectorant 10 mg/5mL; 100 mg/5mL 84379-0316-16 Rnv 474 ml — — FDA listed —
Dextromethorphan HBr. and Guaifenesin 20 mg/10mL; 200 mg/10mL 84415-0011-01 Everpharm 100 cups — — FDA listed —
Dextromethorphan HBr. and Guaifenesin 10 mg/5mL; 100 mg/5mL 84415-0014-01 Everpharm 100 cups — — FDA listed —
Curewell Tussin DM 20 mg/10mL; 200 mg/10mL 85111-0802-16 RMT 473 ml — — FDA listed —
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 10 mg/5mL; 100 mg/5mL 85722-0001-04 KJD 118 ml — — 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

🏛️
1992
On the market since
Jul 1992
📍
2026
Currently FDA-listed
34 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
FlavorCherry
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.

🧪 Avoiding an ingredient? See Dextromethorphan / Guaifenesin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.

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

The official label also statesInactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose.  Sodium Content: 4 mg/5 mL

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

LabelerPAI Holdings, LLC dba PAI Pharma
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00121
First marketedJul 1992
Product typeHuman Otc Drug
Portfolio142 products on file

More NDCs from PAI Holdings, LLC dba PAI Pharma labeler code 00121

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 📦 How Supplied / Storage and Handling 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 30 words ▾

USES helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

⏱️ Dosage and Administration 73 words ▾

DIRECTIONS: Follow dosage below or use as directed by a physician. do not take more than 6 doses in any 24-hour period. age dose adults and children 12 years and over 10 mL (2 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 mL (1 teaspoonful) every 4 hours children 2 years to under 6 years 2.5 mL (1/2 teaspoonful) every 4 hours children under 2 years ask a doctor

⚠️ Warnings 159 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 cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition. you are hypersensitive to any of the ingredients. 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.

📦 How Supplied / Storage and Handling 101 words ▾

HOW SUPPLIED: Guaifenesin Syrup and Dextromethorphan is a red, cherry flavored syrup supplied in the following oral dosage forms: NDC 0121-0638-04: 4 fl oz (118 mL) bottle NDC 0121-0638-08: 8 fl oz (237 mL) bottle NDC 0121-0638-16: 16 fl oz (473 mL) bottle NDC 0121­0638-05: 5 mL unit dose cup NDC 0121-0638-00: Case contains 100 unit dose cups of 5 mL (0121-0638-05) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1276-10: 10 mL unit dose cup NDC 0121-1276-00: Case contains 100 unit dose cups of 10 mL (0121-1276-10) packaged in 10 trays of 10 unit dose cups each.

📦 Storage and Handling 16 words ▾

STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP]. Protect from light.

🧪 Active Ingredient 40 words ▾

DESCRIPTION Each 5 mL (1 teaspoonful) contains: Guaifenesin 100 mg Dextromethorphan Hydrobromide 10 mg Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. Sodium Content: 4 mg/5 mL

🧪 Inactive Ingredients 26 words ▾

Inactive Ingredients: Citric acid, FD&C Red No. 40, flavoring, glycerin, menthol, purified water, sodium benzoate, sodium citrate, sodium saccharin, and sucrose. Sodium Content: 4 mg/5 mL

🎯 Purpose 5 words ▾

Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant

📄 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 32 words ▾

Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

📄 Stop Use and Ask a Doctor If 40 words ▾

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. you are hypersensitive to any of the ingredients.

🤰 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.

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup Label Delivers 5 mL NDC 0121-0638-05 GUAIFENESIN SYRUP and DEXTROMETHORPHAN 100 mg/10 mg per 5 mL Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 5 mL unit dose cup label

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label NDC 0121-0638-04 NSN 6505-01-318-1565 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 4 fl oz (118 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 118 mL bottle label

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label NDC 0121-0638-08 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 8 fl oz (237 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 237 mL bottle label

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0638-16 Quality ® Value Guaifenesin-DM 100 mg/10 mg per 5 mL EXPECTORANT/COUGH SUPPRESSANT Compare to the active ingredients in *Robitussin ®- DM CONTROLS COUGHS LOOSENS AND RELIEVES CHEST CONGESTION 16 fl oz (473 mL) Pharmaceutical Associates, Inc. Greenville, SC 29605 473 mL bottle label

PRINCIPAL DISPLAY PANEL - 10 mL Unit Dose Cup Label Delivers 10 mL NDC 0121-1276-10 GUAIFENESIN SYRUP and DEXTROMETHORPHAN 200 mg/20 mg per 10 mL Package Not Child-Resistant PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT 10 unit dose cup label

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

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 this package alone, 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 – Q1 2026 · 5 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
220
Units reimbursed last 4 qtrs
12.9K
Gross reimbursed last 4 qtrs
$12.3K
Avg / prescription
$55.97
Avg / unit
$0.9554
Latest quarter Q1 2026
81Rx
Fee-for-service vs managed care ⓘ
43% FFS 57% MCO
Fee-for-service · 94 Rx Managed care · 126 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: 8,985 units · 157 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported 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: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 187 units · 0.5 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: 3,541 units · 78.2 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported 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: 175 units · 12.2 per 100k residents HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.5157
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 Minnesota 157 /100k
2 Kentucky 78.2 /100k
3 Hawaii 12.2 /100k
4 California 0.5 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 cups this page00121-0638-00 220 Rx · $12,314
118 ml00121-0638-04 No Medicaid data
237 ml00121-0638-08 No Medicaid data
473 ml00121-0638-16 No Medicaid data
Drug total (last 4 qtrs): 220 Rx · 12,888 units · $12,314 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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) ✓ Available
“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 PAI Holdings, LLC dba PAI Pharma. 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 3 other package presentations of this same product, including 118 ml (00121-0638-04), 237 ml (00121-0638-08), 473 ml (00121-0638-16). 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?
PAI Holdings, LLC dba PAI Pharma 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.
← 00121-0595-00 · Pharmaceutical 00121-0646-10 · PAI →
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.