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Safetussin PM Nighttime Cough relief Dextromethorphan HBr, Doxylamine Succinate 7.5 mg/5mL; 3.125 mg/5mL Liquid — NDC 55505-221-33 (Billing 55505-0221-33)

by Kramer Laboratories · 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC

This is a package of Safetussin PM Nighttime Cough relief Dextromethorphan HBr, Doxylamine Succinate 7.5 mg/5mL; 3.125 mg/5mL Liquid from Kramer Laboratories, no longer marketed (first marketed Jul 2023), no longer in the FDA NDC Directory. It is the main listing for this product, which comes in 2 package sizes.

NDC 55505-0221-33
🏷️ FDA NDC (as labeled) 55505-221-33 billing pads the product segment with a zero
This package
Contains118 mL in 1 bottle, plastic Pack sizes2 compare ↓
Main listing for product 55505-221 · Also comes in: 237 mL 55505-221-36
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55505-221-33
Product NDC 55505-221
11-digit billing NDC 55505022133
RxCUI 1115329
UNII 7355X3ROTS, V9BI9B5YI2
Application # M012
SPL Set ID 33dd2245-9abd-4b32-ac76-0f45a54c0f33
Established class (EPC) Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Sigma-1 Agonist
Mechanism of action Uncompetitive NMDA Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2023-07-28
Route ORAL
Dosage form LIQUID
Substance DEXTROMETHORPHAN; DOXYLAMINE SUCCINATE
Quick answers
  • RxCUI (RxNorm): 1115329
Why two NDCs? The FDA registers this code as 55505-221-33 — 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 → 55505-0221-33. 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

🧪 What is this product?

Safetussin PM Nighttime Cough Relief is an over-the-counter liquid medicine taken by mouth that combines two active ingredients. Dextromethorphan is a cough suppressant typically used to reduce cough. Doxylamine succinate is a sedating antihistamine commonly used to promote sleep. This product is marketed as a nighttime formulation, pairing cough relief with sleep support for nighttime use.

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 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: 237 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55505-0221-33 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC 2023-07-28 — Discontinued by firm
55505-0221-36 55505-221-36 1 BOTTLE, PLASTIC in 1 CARTON / 237 mL in 1 BOTTLE, PLASTIC 2023-07-28 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Safetussin PM Nighttime Cough relief Dextromethorphan HBr, Doxylamine Succinate 7.5 mg/5mL; 3.125 mg/5mL Liquid?
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
Robitussin Maximum Strength Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 00031-8718-13 Haleon 1 bottle — — FDA listed —
Robitussin Honey Maximum Strength Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 00031-8758-12 Haleon 1 bottle — — FDA listed —
Childrens Robitussin Honey Nighttime Cough DM 15 mg/10mL; 6.25 mg/10mL 00031-8762-12 Haleon 1 bottle — — FDA listed —
Walgreens Adult Nighttime Wal Tussin DM Max Maximum Strength 30 mg/20mL; 12.5 mg/20mL 00363-0758-04 WALGREEN 1 bottle — — FDA listed —
Tussin DM Max NIGHTTIME 30 mg/20mL; 12.5 mg/20mL 00363-1043-19 Walgreen 1 bottle — — FDA listed —
tussin nighttime cough 30 mg/20mL; 12.5 mg/20mL 11822-6005-00 Rite 1 bottle — — FDA listed —
topcare tussin dm max 30 mg/20mL; 12.5 mg/20mL 36800-0788-26 Topco 1 bottle — — FDA listed —
meijer Maximum Strength Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 41250-0758-04 MEIJER 1 bottle — — FDA listed —
careone tussin dm 30 mg/20mL; 12.5 mg/20mL 41520-0826-26 American 1 bottle — — FDA listed —
tussin dm nighttime max 30 mg/20mL; 12.5 mg/20mL 42507-0689-26 HyVee 1 bottle — — FDA listed —
Tussin DM Max Nighttime 30 mg/20mL; 12.5 mg/20mL 49035-0943-19 Wal-Mart 1 bottle — — FDA listed —
Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 50844-0043-36 L.N.K. 1 bottle — — FDA listed —
Nighttime Cough 30 mg/20mL; 12.5 mg/20mL 51316-0062-26 CVS 1 bottle — — FDA listed —
Tussin DM Nighttime 30 mg/20mL; 12.5 mg/20mL 51316-0430-36 CVS 1 bottle — — FDA listed —
Cough DM Nighttime 30 mg/20mL; 12.5 mg/20mL 51316-0431-36 CVS 1 bottle — — FDA listed —
Safetussin PM Nighttime Cough relief 7.5 mg/5mL; 3.125 mg/5mLthis 55505-0221-33 Kramer 1 bottle — — Discontinued —
dg health tussin 30 mg/20mL; 12.5 mg/20mL 55910-0709-26 Dolgencorp, 1 bottle — — FDA listed —
Childrens HoneyWorks Plus Nighttime Cough Syrup 15 mg/10mL; 6.25 mg/10mL 68163-0661-04 RARITAN 1 bottle — — FDA listed —
Tussin DM 30 mg/20mL; 12.5 mg/20mL 69842-0699-26 CVS 1 bottle — — FDA listed —
AMAZON Maximim Strength Adult Nighttime Cough DM 30 mg/20mL; 12.5 mg/20mL 72288-0587-04 AMAZON.COM 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
Jul 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.

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.

Manufacturer & labeler

LabelerKramer Laboratories
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code55505
First marketedJul 2023
Product typeHuman Otc Drug
Portfolio26 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Uses temporarily relieves cough runny nose and sneezing

⏱️ Dosage and Administration 40 words ▾

Directions do not take more than 4 doses in any 24-hour period age dose adults and children 12 years and over 20 mL every 6 hours children under 12 years ask a doctor children under 4 years do not use

⚠️ Warnings 61 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 .to make a child sleep.

📦 Storage and Handling 24 words ▾

Other information: Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F) Save this package for complete information

🧪 Active Ingredient 18 words ▾

Active ingredients (in each 5mL) Purpose Dextromethorphan HBr, USP 7.5 mg Cough Suppressant Doxylamine Succinate 3.125 mg Antihistamine

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients : citric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, sucralose

🎯 Purpose 18 words ▾

Active ingredients (in each 5mL) Purpose Dextromethorphan HBr, USP 7.5 mg Cough Suppressant Doxylamine Succinate 3.125 mg Antihistamine

📄 Ask a Doctor Before Use If 36 words ▾

Ask a doctor before use if you have asthma emphysema glaucoma excessive phlegm (mucus) breathing problem chronic bronchitis persistent or chronic cough cough associated with smoking trouble urinating due to enlarged prostate gland a sodium-restricted diet

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

📄 When Using This Product 40 words ▾

When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives and tranquilizers may increase drowsiness

📄 Stop Use and Ask a Doctor If 32 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.

🤰 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 SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES Safetussin ® PM NightTime Cough Relief Dextromethorphan HBr 7.5 mg / Cough Suppressant Doxylamine Succinate 3.125 mg / Antihistamine Safe for adults with High Blood Pressure Diabetes √ Controls Cough √ Relieves Sneezing √ Relieves runny nose SUGAR & ALCOHOL FREE

4.0FL OZ (118mL) SEGURO PARA ADULTOS CON PRESION ALTA Y DIABETES Safetussin ® PM Alivia la Tos Durante la Noche Dextromethorphan HBr 7.5 mg / Antiusivo Doxylamine Succinate 3.125 mg / Antihistaminíco Seguro para adultos con Presión Alta Diabetes √ Calma la tos, √ Alivia estornudos √ Alivia goteo de la nariz SIN AZÚCAR Y SIN ALCOHOL 4 FL. OZ (118 mL) Safetussin ® PM NIGHT TIME COUGH RELIEF Cough Suppressant / Antihistamine Up To 8 Hours of cough relief to help you rest Safetussin ® PM contains: √ No decongestants √ No acetaminophen √ No sugar √ No alcohol √ No sorbitol √ No fructose √ No gluten √ No dyes Pharmacist Recommended Brand Always read and follow label directions.

Do not use longer than 7 consecutive days unless directed by a doctor. Ask a doctor if you have individual health questions. Questions?

Comments? Call 1-800-824-4894 © 2023 Kramer Laboratories, Inc. Bridgewater, NJ 08807 ● kramerlabs.com K0723 PACKAGE LABEL FOR 4 FL OZ (118 mL) Safetussin PM NightTime Cough Relief

4.0 FL OZ (118 mL) PACKAGE LABEL FOR 4 FL OZ (118 mL) Safetussin PM NightTime Cough Relief

8.0 FL OZ (237 mL)

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

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (55505-0221-36). 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?
Kramer Laboratories 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.
← 55505-0220-36 · KRAMER 55505-0222-29 · Kramer →
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.