A3901 SINGLE SHOT EPIDURAL 18G TUOHY/20G TUOHY

Manufacturer
Smiths Medical ASD, Inc. | Aplicare, Inc.
Effective date
2012-05-08
Label type
MEDICAL DEVICE
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:47:15

Label at a glance#

ProductA3901 SINGLE SHOT EPIDURAL 18G TUOHY/20G TUOHY
Active ingredientPOVIDONE-IODINE
Label structure4 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution
[Aplicare, Inc.]

3/4 Ounce Povidone Iodine Packet

WARNINGS SECTION

Povidone-iodine 10%

Antiseptic

Warnings

            Do not use

  • if allergic to iodine
  • in the eyes

            For external use only

            Ask a doctor before use if injuries are

  • deep or puncture wounds
  • serious burns

            Stop use and ask a doctor if

  • redness, irritation, swelling or pain persists or increases
  • infection occurs

            Avoid pooling beneath patient

            Keep out of reach of children.  In case of accidental ingestion, seek professionalassistance or consult a poison control center immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

Povidone Iodine SolutionPovidone Iodine Solution

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label Display Panel

A3901A3901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52380-0001-1ML - Milliliter52380-0001edd25a2a-aabd-433e-b5a8-ef9471c1b24412012-07-24
52380-0001-3ML - Milliliter52380-00019f05eb45-3f8e-4fd9-814a-476eb917bf5c12021-11-09
52380-0001-5EA - Each52380-00019755da7f-19a8-4706-8c70-17752ffe417512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
IODINEACTIVE MOIETY9679TC07X41
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA741
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51688-623851688-6238-2
52380-000152380-0001-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 278 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPRAY, METERED / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74TABLET, EXTENDED RELEASE / ORAL143 mgExact identifier — unii candidate
14 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SUSPENSION / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRAVESICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / PERINEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74SYRUP / ORAL70 mgExact identifier — unii candidate
14 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY, METERED / NASAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRASYNOVIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICONCENTRATE / ORAL10 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / ORAL114 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IENEMA / RECTAL0.44 %v/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTABLE, LIPOSOMAL / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IEMULSION / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS40 mgExact identifier — unii candidate
14 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION / INTRAMUSCULAR40 mgExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / URETHRALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET / ORAL10 mgExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPAEROSOL, FOAM / RECTAL7 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION, EXTENDED RELEASE / ORAL140.8 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS136.55 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR27 mgExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / IONTOPHORESIS0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINHALANT / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISYRUP / ORAL71 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBCUTANEOUS1 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74CREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
14 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASICSODIUM PHOSPHATE, DIBASICGR686LBA74INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS2.98 mgExact identifier — unii candidate
14 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRATHECAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL, METERED / TRANSDERMAL350 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IAEROSOL, FOAM / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IDISC / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTROCHE / ORAL12 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 9 · 165 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Henry Schein Povidone-Iodine Prep PadPOVIDONE-IODINEHenry Schein, Inc.313416b8-60b2-4a77-9b56-5c507aae90722026-09-08WarningsName fallback
generic name: POVIDONE-IODINE
Aplicare Povidone-IodinePOVIDONE-IODINEAplicare Products, LLC7302a2f8-a600-4200-bc4e-309e4c190fe52026-09-02WarningsName fallback
generic name: POVIDONE-IODINE
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCb8a23a29-2541-4987-a534-17a6369a6c8d2026-09-02WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-Iodine Topical AntisepticPOVIDONE-IODINEMedline Industries, LPc9036a83-22f5-4a09-b01c-7093d4192c192026-08-28WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-IodinePOVIDONE-IODINEMajor Pharmaceuticals59041ca3-a195-5a20-e063-6394a90a2ac92026-08-14WarningsName fallback
generic name: POVIDONE-IODINE
Lights Povidone Iodine SwabsticksPOVIDONE-IODINELights Medical Manufacture Co., Ltd.664bbf9f-650a-45fd-b9b8-d93f0ba631902026-07-22WarningsName fallback
generic name: POVIDONE-IODINE
McKesson PVP Prep SolutionPOVIDONE-IODINEMcKesson Medical-Surgical33fa233c-b43c-42d8-af37-a58f098a0d512026-07-21WarningsName fallback
generic name: POVIDONE-IODINE
Aplicare Povidone-iodine ScrubPOVIDONE-IODINEAplicare Products, LLCff19ea2f-d6a0-442f-8f23-d559fc13c5492026-07-14WarningsName fallback
generic name: POVIDONE-IODINE
MedlinePOVIDONE-IODINEMedline Industries, LP1d731a44-f16e-c249-e063-6294a90a39b82026-07-08WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-IodinePOVIDONE-IODINECARDINAL HEALTH 110, LLC. DBA LEADER4f0d8da5-a75b-acc7-e063-6394a90ae8392026-07-08WarningsName fallback
generic name: POVIDONE-IODINE
PVP-I Prep PadPOVIDONE-IODINEProfessional Disposables International, Inc.57b02fbb-a9a6-0b8c-e063-6394a90a44f32026-06-22WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-Iodine Scrub SolutionPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltdefa7f9f6-ae02-4104-bb9e-16e1ffd2be7a2026-06-17WarningsName fallback
generic name: POVIDONE-IODINE
Povidone-IodinePOVIDONE-IODINEH E B4a7a627c-505d-992b-e063-6394a90a54ca2026-06-04Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
Povidone IodinePOVIDONE-IODINEAmerisource Bergenf69a5cec-04f2-4028-94c6-1f129d2de5a92026-06-04WarningsName fallback
generic name: POVIDONE-IODINE
Maokang Povidone-Iodine Paint Solution AntisepticPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd48f81109-3791-46ef-8992-d53b677a51b62026-06-02WarningsName fallback
generic name: POVIDONE-IODINE
Swab Applicator Brushe7.5% w/w Povidone-Iodine (PVP)POVIDONE-IODINEXINXIANG XINDA TECHNOLOGY CO.,LTD51c29301-978a-0d46-e063-6394a90ab9e42026-05-14WarningsName fallback
generic name: POVIDONE-IODINE
Lightning X Iodine Prep PadsPOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd.5136a99b-ef40-937e-e063-6394a90a0a952026-05-07WarningsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINERetail Business Services, LLCad4e49b6-5784-4880-950b-6e6175fc312b2026-04-30Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE
3M Skin and Nasal AntisepticPOVIDONE-IODINESolventum US LLC1a94494d-7dd3-4f32-bc42-81c199fe233e2026-04-22WarningsName fallback
generic name: POVIDONE-IODINE
First Aid AntisepticPOVIDONE-IODINEAmazon.com Services LLC3e2b255c-e3b7-468c-9ac1-b63279c5ac7f2026-03-20Warnings, Adverse reactionsName fallback
generic name: POVIDONE-IODINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.