4385 First Aid Kit

Manufacturer
Honeywell Safety Products USA, Inc.
Effective date
2024-01-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:13:44

Label at a glance#

Product4385 First Aid Kit
Active ingredientALCOHOL, POVIDONE-IODINE, WATER, ISOPROPYL ALCOHOL, SODIUM CHLORIDE
Label structure51 sections

Indications and uses

for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Dosage and administration

remove contacts before using twist top to remove flush the affected area as needed control rate of flow by pressure on the bottle if necessary, continue flushing with emergency eyewash or shower

Label contents#

Full prescribing information#

Eyewash Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sterile Water 99%

Eyewassh Purpose

OTC - PURPOSE SECTION

Eyewash

Eyewash Uses

INDICATIONS & USAGE SECTION

  • for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Eyewash Warnings

WARNINGS SECTION

For external use only

  • Obtain immediate medical treatment for all open wounds in or near eyes.
  • To avoid contamination, do not touch tip of container to any surface.
  • Do not reuse.
  • Once opened, discard.

Do not use

OTC - DO NOT USE SECTION

  • if solution changes color or becomes cloudy
  • if you have open wounds in or near the eyes, get medical help right away.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Eyeash Directions

DOSAGE & ADMINISTRATION SECTION

  • remove contacts before using
  • twist top to remove
  • flush the affected area as needed
  • control rate of flow by pressure on the bottle
  • if necessary, continue flushing with emergency eyewash or shower

Eyewash Inactive ingredients

INACTIVE INGREDIENT SECTION

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyeash Questions

OTC - QUESTIONS SECTION

Call 1-800-430-5490 Honeywell Safety Products USA, Inc. Smithfield, RI 02917

Isotonic Solution for Irrigation.

SPL UNCLASSIFIED SECTION

For Irrigation Only.

Not for Injection.

Description NaCL Irrigation

DESCRIPTION SECTION


Each 100 mL contains:
Sodium Chloride USP 0.9 g; Water for Injection USP qs

pH adjusted with Hydrochloric Acid NF
pH: 5.0 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter

Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154
0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.

The formula of the active ingredient is:
Ingredient Molecular Formula Molecular Weight
Sodium Chloride USP NaCl 58.44

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

The PIC™ Container is PVC-free and DEHP-free.


Ingredient Molecular Formula Molecular Weight
Sodium Chloride USP NaCl 58.44

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

The PIC™ Container is PVC-free and DEHP-free.

Clinical Pharmacology NaCL Irrigant

CLINICAL PHARMACOLOGY SECTION

0.9% Sodium Chloride Irrigation USP is utilized for a variety of clinical indications such as sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters, surgical drainage tubes, and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations.

0.9% Sodium Chloride Irrigation USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection USP (normal saline).

Physiological irrigation solutions are considered generally compatible with living tissues and organs.

Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid.

Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration.

Indication and Usage NaCl Irrigant

INDICATIONS & USAGE SECTION

0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.

Contraindications NaCl Irrigant

CONTRAINDICATIONS SECTION

0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes.

An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Warnings NaCl Irrigant

WARNINGS SECTION

FOR IRRIGATION ONLY. NOT FOR INJECTION.

Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

The risk of dilutional states is inversely proportional to the electrolyte concentrations of the administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.

Do not warm above 150°F (66°C).

After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservatives.

Precautions NaCl Irrigant

PRECAUTIONS SECTION

General
Use aseptic technique when preparing and administering sterile irrigation solutions.

Use only if solution is clear and container and seal are intact.

Do not use for irrigation that may result in absorption of large amounts of fluid into the blood.

Caution should be observed when the solution is used for continuous irrigation or allowed to "dwell" inside body cavities because of possible absorption into the blood stream and the production of circulatory overload.

When used for irrigation via appropriate irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container of appropriate size used for the start up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient.

Laboratory Tests

LABORATORY TESTS SECTION

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance after prolonged irrigation, when fluid absorption is suspected, or whenever the condition of the patient warrants such evaluation.

Drug Interactions

DRUG INTERACTIONS SECTION

Some additives may be incompatible. Consult with pharmacist.When introducing additives, use aseptic technique.Mix thoroughly.

Do not store.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Studies with 0.9% Sodium Chloride Irrigation USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy

PREGNANCY SECTION

Teratogenic Effects

Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Irrigation USP. It is also not known whether 0.9% Sodium Chloride Irrigation USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Irrigation USP should be given to a pregnant woman only if clearly needed.

Labor and Delivery

LABOR & DELIVERY SECTION

Safety and effectiveness of 0.9% Sodium Chloride Irrigation USP during labor and delivery have not been established. Caution should be exercised, and the fluid balance, glucose and electrolyte concentrations, and acid-base balance, of both mother and fetus should be evaluated periodically or whenever warranted by the condition of the patient or fetus.

Nursing Mothers

NURSING MOTHERS SECTION

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 0.9% Sodium Chloride Irrigation USP is administered to a nursing woman.

Pediatric Use

PEDIATRIC USE SECTION

The safety and effectiveness of 0.9% Sodium Chloride Irrigation USP in pediatric patients have not been established. Its limited use in pediatric patients has been inadequate to fully define proper dosage and limitations for use.

Geriatric Use

GERIATRIC USE SECTION

Clinical studies of 0.9% Sodium Chloride Irrigation USP did not include a sufficient number of patients age 65 years and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.Frequent laboratory determinations and clinical evaluations are recommended to monitor changes in blood glucose, electrolyte concentrations, and renal function.

Adverse Reactions

ADVERSE REACTIONS SECTION

Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection.

If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Overdosage

OVERDOSAGE SECTION

In the event of overhydration or solute overload, reevaluate the patient's condition, and institute appropriate corrective treatment. Intravasular volume overload may respond to hemodialysis. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

As required for irrigation.

When used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed.

Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.

Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.

How Supplied

HOW SUPPLIED SECTION

0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Container). The 1000 mL and 500 mL containers are packaged 16 per case, the 2000 mL containers are packaged 8 per case, and the 4000 mL containers are packaged 4 per case.

0.9% Sodium Chloride Irrigation USP


NDC Cat. No. REF SIZE

0264-2201-00 R5200-01 1000 mL
0264-2201-10 R5201-01 500 mL
0264-2201-50 R5205-01 2000 mL
0264-2201-70 R5207 ,,,,4000 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Do not warm above 150°F (66°C).

SPL Unclassified Section

Rx only

Revised: March 2009

PIC is a trademark of B. Braun Medical Inc.

DIRECTIONS FOR USE OF PIC™ (PLASTIC IRRIGATION CONTAINER)

INSTRUCTIONS FOR USE SECTION

Not for injection.

Aseptic technique is required.

Caution – Before use, perform the following checks:

(a) Read the label. Ensure solution is the one ordered and is within the expiration date.

(b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the
container for leakage or damage. Any container which is suspect should not be used.

Use only if solution is clear and container and seal are intact

Single unit container. Discard unused portion.
Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off.

Fig. 1Fig. 1

Figure 1

Connect the administration set through the sterile set port according to set instructions or remove screw cap and pour.

[Fig 2]

Fig 2Fig 2

Figure 2

Do not warm above 150°F (66°C) to assure minimal bottle distortion. Keep bottles upright.

SPL Unclassified Section

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
Made in USA

Y36-002-699

Alcohol Wipe Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 70%

Alcohol Wipe Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Alcohol Wipe Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection in minor cuts, scrapes, and burns

Alcohol Wipe Warnings

WARNINGS SECTION

For external use only

Flammable, keep away from fire and flame

Do not use

OTC - DO NOT USE SECTION

  • in or near eyes
  • over large areas of the body

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not use longer than 1 week unless directed by a doctor

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • condition persists or gets worse

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control center right away

Alcohol Wipe Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • may be covered with a sterile bandage
  • apply wipe to affeted are 1 to 3 times daily
  • discard wipe after single use

Alcohol Wipe Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 15 o to 25 0 C (59 0 to 77 0 oF)
  • do not use if packet is torn or opened

Alcohol Wipe Inactive ingredients

INACTIVE INGREDIENT SECTION

water

Alcohol Wipe Questions

OTC - QUESTIONS SECTION

1-800-430-5490

PVP WipesActive ingredients

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine 10%

(equivalent to 1% titratable iodine)

PVP Wipes Purpose

OTC - PURPOSE SECTION

First aid antiseptic

PVP Wipes Uses

INDICATIONS & USAGE SECTION

  • first aid antiseptic to help prevent infection in minor cuts, scrapes and burns

PVP Wipes Warnings

WARNINGS SECTION

For external use only.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or persists for more than 72 hours
  • irritation and redness develops

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

PVP Wipes Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first
  • discard wipe after single use

PVP Wipes Other Information

SPL UNCLASSIFIED SECTION

  • do not use on individuals who are allergic or sensitive to iodine
  • store at controlled temperature 59-86ºF (15-30ºC)
  • do not use if pouch is open or torn

PVP Wipes Inactive ingredients

INACTIVE INGREDIENT SECTION

nonoxynol 9, water

PVP Wipes Questions

OTC - QUESTIONS SECTION

1-800-430-5490

PAWS Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 66.5%

PAWS Purpose

OTC - PURPOSE SECTION

Antiseptic

PAWS Uses

INDICATIONS & USAGE SECTION

  • for handwashing to decrease bacteria on skin whenever soap and water is not readily available

PAWS Warnings

WARNINGS SECTION

For external use only

Flammable: keep away from fire or flame

Do not use in the eyes.

OTC - DO NOT USE SECTION

If this happens, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation or redness develop and persists for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

PAWS Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands and wrists thoroughly for 15 seconds and allow to air dry
  • always reseal after use
  • children under 6 years of age should be supervised when using this product

PAWS Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, fragrance, purified water, triethanolamine

PAWS Questions

OTC - QUESTIONS SECTION

1-800-430-5490

4385 346100 Kit Contents

SPL UNCLASSIFIED SECTION

1 ALCOHOL PREP PADS 10P

1 PVP IODINE WIPES 10 PER

1 NITRILE GLOVES 2PR BBP

1 O/H TAPE ADHESIVE TRI-CUT

1 BK GZ 4.5"X4.1YD6PLY RL ST MSO

1 FIRST AID GUIDE ASHI

1 EMERGENCY SURVIVAL BLANKET

2 GAUZE CLEAN-WRAP BDGE N/S 2"

1 BLOODSTOPPER

2 ABD COMBINE PAD 5" X 9"

2 ABD PADS 8"X10" STERILE

1 SOD. CHLORIDE 0.9% 500ML EA

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 EMPTY BAG RED 8X8X6

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 POLY BAG, 19 X 24 (CLEAR)

1 BANDAGE PACK FOR KIT

1 ZIP LOCK BAG FOR KIT #3

1 SELF-ADH WRAP 3 X 5 YDS NORTH REV E

1 WATER-JEL BURN DRESSING 4 X 4

1 CORRUGATED 24PK 01-0810 RSC

1 TRI BNDG NON WOVEN 40"X40"X56"

1 COLD PACK UNIT 4"X6" BULK

1 CPR MSK,PAWS WPS,GLVS 1

Eyewash Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EyesalineEyesaline

Principal Display Panel 500 ml Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NaCL Irrigation USPNaCL Irrigation USP

Alcohol Wipe Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alcohol PrepsAlcohol Preps

PVP Wipes Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PVP WipePVP Wipe

PAWS Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PawsPaws

4385 Kit Label 346100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4385 label4385 label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-2201-00ML - Milliliter0264-2201a52a771a-8d79-4b9f-9478-94a22328518612012-07-24
0264-2201-10ML - Milliliter0264-22017f3af6d9-919b-4e82-a1f6-8121315049ac12012-07-24
0264-2201-50ML - Milliliter0264-22013381927e-1220-49c6-9364-6090cd774d4312012-07-24
0264-2201-70ML - Milliliter0264-2201f3dad2db-c85c-4906-9f28-99c55d52af9812012-07-24

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N016733-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N016733-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / IRRIGATIONATRLD, RS, Approved before 1982f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N016733-001AT184e616aacf4f…
2026-08-18 06:07:402026-07N016733-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016733-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016733-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016733-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016733-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016733-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016733-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016733-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016733-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016733-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016733-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016733-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016733-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016733-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016733-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016733-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016733-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016733-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016733-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016733-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016733-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016733-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N016733-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016733-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016733-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016733-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N016733-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N016733-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016733-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016733-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016733-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016733-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016733-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016733-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016733-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N016733-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N016733-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016733-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N016733-001AT1f41ea6bd6efb…

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.0d59a04a-32e6-485b-b638-a1e6c09e96422025-07-09Warnings, Adverse reactionsExact identifier
ndc (product): 0264-2201
1a13d493-bf8a-200e-e063-6394a90a6cae94989d62-387b-200e-e053-2a95a90a3e442024-06-04Warnings, Adverse reactionsExact identifier
spl set id: 94989d62-387b-200e-e053-2a95a90a3e44

Reported adverse events (FAERS/openFDA)#

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