Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy
⚠️
Other active recalls for Glycerin (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 27, 2026 — Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. (Oasis Medical, Inc.)· FDA recall D-0525-2026
Class II · Apr 20, 2026 — Lack of Assurance of Sterility (SCOPE HEALTH)· FDA recall D-0499-2026
Class II · Mar 25, 2026 — Lack of Assurance of Sterility (Preferred Pharmaceuticals, Inc.)· FDA recall D-0443-2026
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc)· FDA recall D-0411-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Established class (EPC)Non-Standardized Chemical Allergen
Physiologic effectIncreased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical classAllergens; Glycerol
DEA scheduleNon-controlled
Marketing categoryOTC MONOGRAPH DRUG
Marketing statusOn market
FDA listing statusListed (active directory)
Marketing start2013-09-12
RouteRECTAL
Dosage formSUPPOSITORY
SubstanceGLYCERIN
GPI-1446600010005250
GPI classGNP Glycerin (Adult)
GCN Seq No002982
GCN08860
HICL code001312
Ingredient (HICL)Glycerin
HIC1 codeQ
Therapeutic class — broad (HIC1)Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 codeQ3
Therapeutic class — intermediate (HIC2)Anal-Rectal Preparations
HIC3 codeQ3S
Therapeutic class — specific (HIC3)Laxatives, Local/Rectal
AHFS code56:12.00.00
AHFS classCathartics And Laxatives
FDB label nameGLYCERIN SUPPOSITORY
FDB brand nameGlycerin
Legend statusO — Over-the-counter (OTC) drug or device
Why two NDCs?
The FDA registers this code as 46122-221-63 — 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 → 46122-0221-63. 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 Non-Standardized Chemical Allergen class.
Pharmacologic classNon-Standardized Chemical Allergen
Drug family (ATC)Enemas, Other drugs for constipation
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.
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 GLYCERIN SUPPOSITORYIngredient Glycerin
🧪 What is this product?
Glycerin 2.1 g/1 Suppository is an over-the-counter rectal suppository containing glycerin as its active ingredient. Glycerin is commonly used in suppository form to help soften stool and promote bowel movements. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for its category rather than undergoing individual product review. Suppositories of this type are typically used to address occasional constipation or to facilitate bowel regularity.
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.
💬 Questions about Glycerin?
Ask a licensed pharmacist directly — free, answered by our team.
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 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
UNII 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.
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.
3 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statespurified water, sodium hydroxide, 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 system
Per ea
Per package
Retail pharmacies payNADAC · weekly
$0.103
$2.58 / 25 suppositories
Medicaid paysCMS SDUD · 12 mo
$0.3754
$9.39 / 25 suppositories
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
▲ Up 19% over the last 10 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.
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
🏛️
2013
On the market since
Sep 2013
📍
2026
Currently FDA-listed
13 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 46122-0221-63, 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
92
Units reimbursed last 4 qtrs
1.5K
Gross reimbursed last 4 qtrs
$574.69
Avg / prescription
$6.25
Avg / unit
$0.3754
Latest quarter Q1 2026
12Rx
Medicaid pays / ea
$0.3754
gross reimbursed
vs
NADAC / ea
$0.1030
acquisition cost
=
Spread
+$0.2724
+264% 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 ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 92 Rx
State Medicaid map
Units reimbursed · per 100k residents
14.221.0
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
1Oregon21.0 /100k
2Kentucky14.2 /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.
Drug total (last 4 qtrs): 92 Rx · 1,531 units · $575 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
🔬 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 Glycerin — the ingredient across all brands.
Top reported reactions
Oral Herpes2,427
Condition Aggravated2,018
Eye Irritation1,068
Eye Pain1,013
Incorrect Drug Administration Duration806
Pain758
Herpes Simplex709
Age at onset
Neonate3
Infant11
Child22
Adolescent14
Adult831
Elderly1,496
Reporter sex
Male · 27%
Female · 73%
Unknown · 0%
Serious outcomes
Hospitalization2,612
Death681
Life-threatening414
Disabling225
Reports over time (by year) — tap or hover for the count & year
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.
What is the difference between NDC 46122-0221-63 and NDC 46122-0221-71?
Both are Glycerin 2.1 g Suppository — the drug itself is identical. NDC 46122-0221-63 is the 25 suppositories package, while NDC 46122-0221-71 is the 50 suppositories package. Per-ea NADAC also differs: $0.1030 here vs $0.0679 for the 50 suppositories pack.
What NDC number is used to bill for this package of Glycerin 2.1 g Suppository?
Bill NDC 46122-0221-63 — the 11-digit billing format is 46122022163. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 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.
Uses for relief of occasional constipation this product generally produces a bowel movement in 1/4 to 1 hour
⏱️Dosage and Administration43 words▾
Directions Single daily dosage adults and children 6 years and over 1 suppository, or as directed by a doctor children 2 to under 6 years use Child Suppositories Insert suppository well up into rectum. Suppository need not melt completely to produce laxative action.
⚠️Warnings91 words▾
Warnings For rectal use only May cause rectal discomfort of burning sensation Ask a Doctor before using any laxative if you have abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than two weeks already used a laxative for more than 1 week Stop use and consult a doctor if you have rectal bleeding no bowel movement after using this product These symptoms may indicate a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
🧪Active Ingredient8 words▾
Active ingredient (in each suppository) Glycerin 2.1 g
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.