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Pediacare Childrens Cough and Congestion Grape DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN 5 mg/5mL; 100 mg/5mL Syrup

by RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH · 1 BOTTLE in 1 CARTON (52412-992-01) / 118 mL in 1 BOTTLE
NDC 52412-0992-01
🏷️ FDA NDC (as labeled) 52412-992-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 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) 52412-992-01
Product NDC 52412-992
11-digit billing NDC 52412099201
RxCUI 1020138
UNII 9D2RTI9KYH, 495W7451VQ
UPC 0030103092053
Application # M012
SPL Set ID 9576723b-748c-45e7-bc0d-cc109b9f6735
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 2023-01-03
Route ORAL
Dosage form SYRUP
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Why two NDCs? The FDA registers this code as 52412-992-01 — 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 → 52412-0992-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the 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

LabelerRANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code52412
First marketedJan 2023
Product typeHuman Otc Drug
Portfolio5 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

📗 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.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good neighbor pharmacy tussin dm max 20 mg/20mL; 400 mg/20mL 46122-0541-34 Amerisource 1 bottle $0.018 — Availability likely —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 70000-0565-01 Cardinal 177 ml $0.020 — Discontinued —
Mucus Relief DM 20 mg/20mL; 400 mg/20mL 70000-0707-01 Cardinal 177 ml $0.021 — Availability likely —
QCH Maximum Strength Mucus Relief DM 628 20 mg/20mL; 400 mg/20mL 83324-0026-06 Chain 177 ml $0.021 — Availability likely —
Good Sense Tussin DM Max 20 mg/20mL; 400 mg/20mL 00113-0927-26 L. 1 bottle $0.023 — Availability likely —
Good Neighbor Childrens Cough Relief Cherry Flavor 5 mg/5mL; 100 mg/5mL 46122-0786-29 AMERISOURCE 1 bottle $0.023 — Availability likely —
Tussin DM 20 mg/20mL; 400 mg/20mL 70000-0628-01 Cardinal 1 bottle $0.023 — Availability likely —
Foster and Thrive Adult Tussin DM MAX 20 mg/20mL; 400 mg/20mL 70677-1036-01 Strategic 1 bottle $0.023 — Availability likely —
Childrens Delsym Cough Plus Chest Congestion DM 5 mg/5mL; 100 mg/5mL 63824-0214-64 Reckitt 1 bottle $0.059 — FDA listed —
Mucinex Childrens Cough 5 mg/5mL; 100 mg/5mL 63824-0946-03 Reckitt 1 bottle $0.059 — FDA listed —
Delsym Cough Plus Chest Congestion DM 20 mg/20mL; 400 mg/20mL 63824-0213-66 Reckitt 180 ml $0.062 — FDA listed —
Mucinex Fast-Max DM Max Honey and Berry Flavor 20 mg/20mL; 400 mg/20mL 63824-0535-66 Reckitt 180 ml $0.062 — FDA listed —
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM 20 mg/20mL; 400 mg/20mL 00031-2097-01 Haleon 1 bottle — — FDA listed —
Childrens Robitussin Elderberry Cough and Chest Congestion DM 20 mg/20mL; 400 mg/20mL 00031-2098-01 Haleon 1 bottle — — FDA listed —
Childrens Robitussin Cough and Chest Congestion DM 5 mg/5mL; 100 mg/5mL 00031-8715-10 Haleon 1 bottle — — FDA listed —
Robitussin Maximum Strength Cough Plus Chest Congestion Dm 20 mg/20mL; 400 mg/20mL 00031-8739-12 Haleon 1 bottle — — FDA listed —
Robitussin Honey Maximum Strength Cough and Chest Congestion DM 20 mg/20mL; 400 mg/20mL 00031-8756-12 Haleon 1 bottle — — FDA listed —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 00363-0505-06 Walgreens 177 ml — — Discontinued —
Cough and Chest Congestion DM Maximum Strength 20 mg/20mL; 400 mg/20mL 00363-0506-06 Walgreens 177 ml — — FDA listed —
tussin dm max 20 mg/20mL; 400 mg/20mL 00363-1144-26 Walgreen 1 bottle — — FDA listed —
Mucus Relief Cough Childrens 5 mg/5mL; 100 mg/5mL 00363-5527-04 Walgreens 1 bottle — — FDA listed —
Mucus Relief DM Honey and Berry Flavor 20 mg/20mL; 400 mg/20mL 00363-6005-06 WALGREENS 180 ml — — FDA listed —
Walgreen Cough and Chest Congestion 20 mg/20mL; 400 mg/20mL 00363-7296-06 WALGREEN 180 ml — — FDA listed —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 00363-7390-06 WALGREENS 180 ml — — FDA listed —
Walgreens Daytime Childrens 5 mg/5mL; 100 mg/5mL 00363-7550-04 WALGREENS 118 ml — — FDA listed —
Adult Cough plus Chest Congestion DM with Honey 20 mg/20mL; 400 mg/20mL 00363-7754-04 WALGREEN 1 bottle — — FDA listed —
DM Max 20 mg/20mL; 400 mg/20mL 00363-8031-45 Walgreen 177 ml — — FDA listed —
7 Select Maximum Strength 20 mg/20mL; 400 mg/20mL 10202-0740-04 7-ELEVEN 1 bottle — — FDA listed —
up and up cough plus chest congestion 20 mg/20mL; 400 mg/20mL 11673-0627-26 Target 1 bottle — — Discontinued —
tussin cough chest congestion 20 mg/20mL; 400 mg/20mL 11822-1332-01 Rite 1 bottle — — FDA listed —
Mucus DM 20 mg/20mL; 400 mg/20mL 11822-5050-06 Rite 177 ml — — FDA listed —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 21130-0505-06 Safeway, 177 ml — — Discontinued —
tussin 20 mg/20mL; 400 mg/20mL 21130-0707-26 Safeway 1 bottle — — FDA listed —
Mucus Relief DM 20 mg/20mL; 400 mg/20mL 30142-0508-06 The 177 ml — — FDA listed —
tussin dm max 20 mg/20mL; 400 mg/20mL 30142-0843-26 Kroger 1 bottle — — FDA listed —
Mucus Relief DM Max Maximum Strength 20 mg/20mL; 400 mg/20mL 36800-0605-06 TOP 177 ml — — FDA listed —
topcare tussin dm max 20 mg/20mL; 400 mg/20mL 36800-0847-26 Topco 1 bottle — — FDA listed —
Maximum Strength DM MAX 20 mg/20mL; 400 mg/20mL 37808-0518-25 H 177 ml — — FDA listed —
Mucus Relief Cough Childrens 5 mg/5mL; 100 mg/5mL 37808-0594-04 H 1 bottle — — FDA listed —
tussin 20 mg/20mL; 400 mg/20mL 37808-0639-26 H 1 bottle — — FDA listed —
equaline tussin 20 mg/20mL; 400 mg/20mL 41163-0704-26 United 1 bottle — — FDA listed —
KROGER Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 41226-0739-06 KROGER 180 ml — — FDA listed —
adult dm max cough and chest congestion 20 mg/20mL; 400 mg/20mL 41250-0261-34 Meijer 1 bottle — — FDA listed —
Meijer Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 41250-0748-06 MEIJER, 180 ml — — FDA listed —
careone tussin dm 20 mg/20mL; 400 mg/20mL 41520-0931-26 American 1 bottle — — FDA listed —
Maximum Strength Mucus Relief 20 mg/20mL; 400 mg/20mL 42507-0630-58 Hyvee 177 ml — — FDA listed —
Good Neighbor Pharmacy Mucus Relief Dm Maximum Strength 20 mg/20mL; 400 mg/20mL 46122-0840-29 AMERISOURCE 180 ml — — FDA listed —
equate adult tussin dm max 20 mg/20mL; 400 mg/20mL 49035-0705-26 Wal-Mart 1 bottle — — FDA listed —
Childrens Cough 5 mg/5mL; 100 mg/5mL 49035-0773-03 Wal-Mart 1 bottle — — FDA listed —
Maximum Strength Mucus Relief DM 20 mg/20mL; 400 mg/20mL 49035-0839-06 Wal-Mart 180 ml — — FDA listed —
Tussin DM Max 20 mg/20mL; 400 mg/20mL 49035-0930-19 Wal-Mart 1 bottle — — FDA listed —
Tussin DM Daytime 20 mg/20mL; 400 mg/20mL 51316-0304-19 CVS 1 bottle — — FDA listed —
Cough and Chest Congestion DM Daytime 20 mg/20mL; 400 mg/20mL 51316-0305-19 CVS 1 bottle — — FDA listed —
DM Maximum 20 mg/20mL; 400 mg/20mL 51316-0310-45 CVS 177 ml — — FDA listed —
Cough and Chest Congestion DM 20 mg/20mL; 400 mg/20mL 51316-0389-45 CVS 177 ml — — FDA listed —
Cough and Congestion 20 mg/20mL; 400 mg/20mL 51316-0500-19 CVS 1 bottle — — FDA listed —
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 51316-0552-03 CVS 1 bottle — — FDA listed —
CVS Maximum Strength 20 mg/20mL; 400 mg/20mL 51316-0740-04 CVS 1 bottle — — FDA listed —
CVS Adult Cough plus Chest Congestion DM Max with Honey 20 mg/20mL; 400 mg/20mL 51316-0775-08 CVS 1 bottle — — FDA listed —
daytime cough and chest congestion dm 20 mg/20mL; 400 mg/20mL 51316-0826-26 CVS 1 bottle — — FDA listed —
Pediacare Childrens Cough and Congestion Grape 5 mg/5mL; 100 mg/5mLthis 52412-0992-01 RANDOB 1 bottle — — FDA listed —
Maximum strength Tussnex FM DM Max 20 mg/20mL; 400 mg/20mL 53041-0628-58 Guardian 177 ml — — FDA listed —
DM Max CONGESTION and COUGH 20 mg/20mL; 400 mg/20mL 53942-0518-25 DeMoulas 177 ml — — FDA listed —
Childrens Cough Mucus Relief 5 mg/5mL; 100 mg/5mL 53943-0512-24 Discount 118 ml — — FDA listed —
Maxium Strength Dm Max 20 mg/20mL; 400 mg/20mL 53943-0518-25 Discount 117 ml — — FDA listed —
Mucus Relief DM Max 20 mg/20mL; 400 mg/20mL 55319-0731-45 Family 177 ml — — FDA listed —
Maximum Strength Adult Cough plus Chest Congestion DM 20 mg/20mL; 400 mg/20mL 55319-0740-04 FAMILY 1 bottle — — FDA listed —
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 55319-0924-03 Family 1 bottle — — FDA listed —
SanaTos Children Cough and Congestion Cherry 100 mg/5mL; 5 mg/5mL 55758-0013-04 Pharmadel 1 bottle — — FDA listed —
SanaTos Mucus Relief Cold Toddlers 50 mg/2.5mL; 2.5 mg/2.5mL 55758-0307-02 Pharmadel 59 ml — — FDA listed —
Mucus Relief DM Max 20 mg/20mL; 400 mg/20mL 55910-0146-95 DOLGENCORP, 266 ml — — FDA listed —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 55910-0505-08 Dolgencorp, 266 ml — — FDA listed —
rexall dm cough and congestion relief 20 mg/20mL; 400 mg/20mL 55910-0755-26 Dolgencorp, 1 bottle — — FDA listed —
GeriCare Tussin DM Max 20 mg/20mL; 400 mg/20mL 57896-0591-08 GERI-CARE 237 ml — — FDA listed —
Mucinex Fast-Max DM Max 20 mg/20mL; 400 mg/20mL 63824-0019-22 Reckitt 2 bottles — — Discontinued —
Mucus Relief DM Max Maximum Strength 20 mg/20mL; 400 mg/20mL 63868-0235-06 QUALITY 177 ml — — Discontinued —
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 63868-0771-04 Chain 1 bottle — — FDA listed —
DM Max 20 mg/20mL; 400 mg/20mL 63941-0518-25 Best 177 ml — — FDA listed —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 67091-0342-06 WINCO 180 ml — — FDA listed —
Premier Value Maximum Strength 20 mg/20mL; 400 mg/20mL 68016-0740-04 PHARMACY 1 bottle — — FDA listed —
Mucus Relief DM Honey and Berry Flavor 20 mg/20mL; 400 mg/20mL 68163-0605-06 RARITAN 180 ml — — FDA listed —
berkley and jensen tussin dm 20 mg/20mL; 400 mg/20mL 68391-0299-34 BJWC 1 bottle — — FDA listed —
Berkley and Jensen Tussin DM Max 20 mg/20mL; 400 mg/20mL 68391-0711-34 BJWC 1 bottle — — FDA listed —
Mucus Relief DM Max Maximum Strength 20 mg/20mL; 400 mg/20mL 69256-0505-06 Harris 177 ml — — FDA listed —
Tussin DMMax 20 mg/20mL; 400 mg/20mL 69618-0072-58 RELIABLE 1 bottle — — FDA listed —
Kids Cough and Chest Congestion 100 mg/5mL; 5 mg/5mL 69676-0037-09 Genexa 1 bottle — — FDA listed —
CVS Childrens Cough Relief 5 mg/5mL; 100 mg/5mL 69842-0577-04 CVS 1 bottle — — FDA listed —
tussin dm 20 mg/20mL; 400 mg/20mL 69842-0819-26 CVS 1 bottle — — FDA listed —
Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 69842-0904-06 CVS 177 ml — — FDA listed —
Cough and Chest Congestion DM Adult 20 mg/20mL; 400 mg/20mL 69842-0926-06 CVS 177 ml — — FDA listed —
CVS Mucus Relief DM Maximum Strength 20 mg/20mL; 400 mg/20mL 69842-0937-06 CVS 180 ml — — FDA listed —
Childrens Mucus and Cough Relief 5 mg/5mL; 100 mg/5mL 70000-0630-01 CARDINAL 1 bottle — — FDA listed —
basic care tussin dm max 20 mg/20mL; 400 mg/20mL 72288-0293-34 Amazon.com 1 bottle — — FDA listed —
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum Strength 400 mg/1; 20 mg 72854-0159-66 Reckitt 180 liquids — — FDA listed —
Dr Kids Cough and Chest Congestion 100 mg/5mL; 5 mg/5mL 73282-2523-02 CalmCo 18 vials — — FDA listed —
Childrens Mucus Relief Cough Cherry Liquid 5 mg/5mL; 100 mg/5mL 76162-0294-04 Topco 1 bottle — — FDA listed —
Maximum Strength Mucus Relief DM Max 20 mg/20mL; 400 mg/20mL 76162-0628-58 Topco 177 ml — — FDA listed —
TOPCO Childrens Cough Relief 5 mg/5mL; 100 mg/5mL 76162-0751-04 Topco 1 bottle — — FDA listed —
Childrens Mucus Relief Cough - Cherry Flavor 5 mg/5mL; 100 mg/5mL 76281-0512-24 AptaPharma 1 bottle — — FDA listed —
Target Childrens Cough Relief 5 mg/5mL; 100 mg/5mL 82442-0751-04 TARGET 1 bottle — — FDA listed —
Mucus Relief Cough and Congestion Childrens 5 mg/5mL; 100 mg/5mL 82673-0102-04 KinderFarms, 1 bottle — — FDA listed —
AXIM DM Max 20 mg/20mL; 400 mg/20mL 82706-0013-01 VIVUNT 177 ml — — FDA listed —
AXIV DM Max 20 mg/20mL; 400 mg/20mL 82706-0024-01 VIVUNT 177 ml — — FDA listed —
Mucus Relief DM 20 mg/20mL; 400 mg/20mL 83324-0323-06 Chain 177 ml — — FDA listed —
Tussin DM 20 mg/20mL; 400 mg/20mL 83324-0324-04 Chain 1 bottle — — FDA listed —
Dr. Simi Children s Cough 5 mg/5mL; 100 mg/5mL 85786-0604-04 Farmacias 1 bottle — — 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

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 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.

🔬 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 Pediacare Childrens Cough and Congestion Grape (this brand).

Top reported reactions

Dizziness16
Diarrhoea13
Insomnia9
Cough8
Nausea7
Headache6
Blood Pressure Increased5

Age at onset

Adult3
Elderly3

Reporter sex

139 reports
Male · 43%
Female · 57%

Serious outcomes

Hospitalization15
Life-threatening3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 20 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
52412-0992-01 You're viewing this 1 BOTTLE in 1 CARTON (52412-992-01) / 118 mL in 1 BOTTLE 2023-01-03 Active

🧭 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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 52412-992-01, 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: 52412-0992-01, written without dashes as 52412099201. 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 52412-0992-01, the first segment (52412) is the labeler code FDA assigned to RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH; the middle segment (0992) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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: this package is listed as actively marketed, with no marketing end date reported by RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 words ▾

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

⏱️ Dosage and Administration 67 words ▾

Directions do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product mL=milliliter AGE DOSE children under 4 years do not use children 4 to under 6 years 5 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours adults and children 12 years and over 20 mL every 4 hours

⚠️ Warnings 151 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 persistant headache.

These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

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

📦 Storage and Handling 10 words ▾

Other information store at 20-25°C (68-77°F) do not refrigerate alcohol-free

🧪 Active Ingredient 19 words ▾

Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr, USP 5 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant

🧪 Inactive Ingredients 21 words ▾

Inactive ingredients acesulfame potassium, citric acid anhydrous, glycerin, flavor, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin

🎯 Purpose 19 words ▾

Active ingredients (in each 5 mL) Purposes Dextromethorphan HBr, USP 5 mg Cough suppressant Guaifenesin, USP 100 mg Expectorant

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