Nix Complete Maximum Strength Lice Elimination

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2020-07-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:23:52

Label at a glance#

ProductNix Complete Maximum Strength Lice Elimination
Active ingredientPERMETHRIN
Label structure17 sections

Indications and uses

treats head lice

Dosage and administration

Important: Read warnings before use Adults and children 2 months old and older Inspect all household members should be checked by another person for lice and/or nits (eggs use a magnifying glass in bright light to help you see the lice and/or nits (eggs) use a tool, such as a comb or two unsharpened pencils to lift and part the hair look for tiny nits near scalp, beginning at back of neck and behind ears small sec...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

[1 Eliminate] Creme Rinse

Drug Facts

Active ingredient (in each fluid ounce)

OTC - ACTIVE INGREDIENT SECTION

Permethrin 280 mg (1%)

Purpose

OTC - PURPOSE SECTION

Lice treatment

Uses

INDICATIONS & USAGE SECTION

treats head lice

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on children under 2 months of age
  • near the eyes
  • inside the nose, ear, mouth, or vagina
  • on lice in eyebrows or eyelashes.
    See your doctor.

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

  • allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

When using this product

OTC - WHEN USING SECTION

  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets into the eyes, immediately flush with large amounts of water
  • scalp itching or redness may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Important: Read warnings before use

  • Adults and children 2 months old and older

Inspect

  • all household members should be checked by another person for lice and/or nits (eggs
  • use a magnifying glass in bright light to help you see the lice and/or nits (eggs)
  • use a tool, such as a comb or two unsharpened pencils to lift and part the hair
  • look for tiny nits near scalp, beginning at back of neck and behind ears
  • small sections of hair (1-2 inches wide) should be examined at a time
  • unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched,
  • if either lice or nits (or eggs) are found, treat with Nix® Creme Rinse

Treat

  • wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Nix®. Rinse with water.
  • towel dry hair so it is damp but not wet
  • shake the bottle of Nix® well
  • completely saturate the hair and scalp with Nix®. Begin to apply Nix® behind the ears and at the back of the neck.
  • keep Nix® out of the eyes. Protect the eyes with a washcloth or towel.
  • leave Nix® on the hair for 10 minutes, but no longer
  • rinse with warm water
  • towel dry hair and comb out tangles
  • if live lice are seen seven days or more after the first treatment, a second treatment should be given

Remove Lice/Nits

  • remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out.
  • use the nit comb provided and make sure the hair remains slightly damp while removing nits
  • if the hair dries during combing, dampen it slightly with water
  • part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours).
  • start at the top of the head on the section you have picked
  • with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair.
  • use clips to pin back each strand of hair after you have combed out the nits
  • clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back.
  • after combing, recheck the entire head for nits and repeat combing if necessary
  • check the affected head daily to remove any nits that you might have missed

Other information

SPL UNCLASSIFIED SECTION

  • read all the directions in the Consumer Information Insert and warnings before use. Keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

balsam canada, cetyl alcohol, citric acid, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethylcellulose, polyoxyethylene 10 cetyl ether, propylene glycol, stearalkonium chloride, water, isopropyl alcohol, methylparaben, propylparaben

Questions?

OTC - QUESTIONS SECTION

1-888-542-3546

[2 Remove] Combing Gel & Comb

Product Facts

Uses

INDICATIONS & USAGE SECTION

To detangle and comb the hair

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use after shampooing with lice killing creme rinse
  • towel dry hair
  • apply combining gel until all the hair and scalp is thoroughly wet with product
  • make sure product covers the area behind the ears and at the nape of the neck where there are more likely to be nits
  • part hair into sections and clip back
  • use the enclosed special-toothed comb to comb out dead lice and nits
  • comb out one section at a time
  • it is extremely important to comb out dead lice and nits
  • if hair begins to dry, reapply additional product
  • when you finish combing, rinse hair thoroughly with warm water. 

Other Information

SPL UNCLASSIFIED SECTION

  • Nix Combing Gel does not kill lice and nits
  • Pesticide free
  • Keep carton for full information and warnings. Read all warnings and directions before use.
  • Visit our website at nixlice.com

Ingredients

INACTIVE INGREDIENT SECTION

water, propylene glycol, glycerin, polyquaternium-10, diazolidinyl urea, hydroxyethylcellulose, sodium citrate dihydrate, citric acid, methylparaben, propylparaben, disodium EDTA

[3 Control] Nix ® Lice Control Spray

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

PERMETHRIN 0.25%

(CAS # 52645-53-1)

Other ingredients: 

SPL UNCLASSIFIED SECTION

99.75%

100.00%

NOT FOR USE ON HUMANS. READ ENTIRE LABEL BEFORE EACH USE. SHAKE BOTTLE WELL BEFORE USING.

Precautionary Statements

ENVIRONMENTAL HAZARDS

This product is extremely toxic to fish and aquatic organisms. To protect the environment, do not allow pesticide to enter or run off into storm drains, drainage ditches, gutters or surface waters.

Directions For Use

It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

For Use in Non-food Areas of Homes

Indoor Application

Surface Spraying: To kill lice and louse eggs, spray in an inconspicuous area to test for possible staining or discoloration. Inspect again after drying, then proceed to spray entire area to be treated. Spray from a distance of 8 to 10 inches. Treat only those garments and parts of bedding, including mattresses and furniture, that cannot be either laundered or dry cleaned. Allow all treated articles to dry thoroughly before use.

To control bedbugs: Spray mattresses lightly, particularly around tufts and seams. Take beds apart and spray in all joints. Allow all sprayed articles to dry thoroughly before use.

  • Do not use in food/feed areas of food/feed handling establishments, restaurants or other areas where food/feed is commercially prepared or processed. Do not use in serving areas while food is exposed or facility is in operation. Serving areas are areas where prepared foods are served such as dining rooms, but excluding areas where foods may be prepared or held.
  • In the home, cover all food handling surfaces, cover or remove all food and cooking utensils or wash thoroughly after treatment.
  • Application is prohibited directly into sewers or drains, or into any area like a gutter where drainage to sewers, storms drains, water bodies, or aquatic habitat can occur. Do not allow the product to enter any drain during or after application.

Storage and Disposal

Do not contaminate water, food or feed by storing or disposal.

Pesticide Storage and Spill Procedures: Keep from freezing. Store upright at room temperature. Avoid exposure to extreme temperatures. In case of spill or leakage, soak up with an absorbent material such as sand, sawdust, earth, fuller's earth, etc. Dispose of with chemical waste.

Pesticide Disposal: If partly filled – Call your local solid waste agency for disposal instructions. Never place unused product down any indoor or outdoor drain. Container Disposal: If empty – Nonrefillable container.

Do not reuse or refill this container. Place in trash or offer for recycling if available.

EPA REG. NO. 64321-1-75406

EPA EST. NO. 91705-NJ-001

Dist. by INSIGHT Pharmaceuticals Corp.

660 White Plains Road, Tarrytown, NY 10591, a Prestige Brands Company

©2017 Trade dress is owned by INSIGHT Pharmaceuticals Corp. All rights reserved. RID® is a registered trademark of Bayer Healthcare, LLC.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nix® Complete Lice Treatment Kit
Permethrin Creme Rinse (1%)

Creme Rinse 2 Bottles 2 fl oz (59 mL) EACH,
Combing Gel 2 fl oz (59 mL), Lice Comb, Lice Control Spray 5 fl oz (147.86 mL)
nixlice.com

PRINCIPAL DISPLAY PANEL Nix® Complete Lice Treatment Kit Permethrin Creme Rinse (1%) Creme Rinse 2 Bottles 2 fl oz (59 mL) EACH, Combing Gel 2 fl oz (59 mL), Lice Comb, Lice Con...PRINCIPAL DISPLAY PANEL Nix® Complete Lice Treatment Kit Permethrin Creme Rinse (1%) Creme Rinse 2 Bottles 2 fl oz (59 mL) EACH, Combing Gel 2 fl oz (59 mL), Lice Comb, Lice Con...

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-027-062020-06-29C16284748780-19d75b9d0-7dce-f424-e053-dadaa90a57ceNix Complete Lice Treatment Kit
63736-027-062020-01-31C16284748780-19d75b9d0-7dce-f424-e053-dadaa90a57ceNix Complete Lice Treatment Kit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63736-024-03ML - Milliliter63736-024edae0d8b-ee49-4c7a-9d75-27b6627413e912017-10-13
63736-024-04ML - Milliliter63736-024dadced74-ab25-4fa4-af43-6eae607d479e12019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PermethrinACTIVE INGREDIENT509F88P9SZ1
PermethrinACTIVE MOIETY509F88P9SZ1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSL1
canada balsamINACTIVE INGREDIENTK304VI98I31
ceteth-10INACTIVE INGREDIENTLF9X1PN3XJ1
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A81
isopropyl alcoholINACTIVE INGREDIENTND2M4163021
methylparabenINACTIVE INGREDIENTA2I8C7HI9T1
propylene glycolINACTIVE INGREDIENT6DC9Q167V31
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
stearalkonium chlorideINACTIVE INGREDIENT0OUO26BB881
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-02763736-027-06
63736-024

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML · Source PDF

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 6 · 355 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHLIQUID / TOPICAL0.1 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
isopropyl alcoholISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / BUCCAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / ORAL64 mgExact identifier — unii candidate
68 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii candidate
61 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, DELAYED RELEASE / ORAL0.02 mgExact identifier — unii candidate
34 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION / ORAL11 mgExact identifier — unii candidate
34 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8LOTION / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLGRANULE, FOR SUSPENSION / ORAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii candidate
79 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS414 mgExact identifier — unii candidate
61 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING / SUBLINGUALADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION, CONCENTRATE / INTRAVENOUS60 mgExact identifier — unii candidate
61 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHGEL / VAGINAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8SOLUTION / ORAL75.3 mg/15mlExact identifier — unii candidate
34 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHENEMA / RECTAL0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCAPSULE / ORAL1 mgExact identifier — unii candidate
68 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8LIQUID / ORAL0.2 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8POWDER / ORAL20 mgExact identifier — unii candidate
34 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii candidate
79 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLOIL / TOPICAL2 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C yellow no. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED / ORAL0.03 mgExact identifier — unii candidate
34 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
canada balsamCANADA BALSAMK304VI98I3LOTION / TOPICAL0.5 %w/wExact identifier — unii candidate
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii candidate
61 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
anhydrous citric acidANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / RECTAL904 mgExact identifier — unii candidate
61 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates

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
N019918-001NIXPERMETHRIN1%LOTION / TOPICALRLD, RS1990-05-02

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 22:38:342026-08N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0284e616aacf4f…
2026-08-18 06:07:402026-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-0287673890dc5c…
2021-03-12 10:30 UTC2021-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023f01610625f2…
2019-09-15 20:21 UTC2019-09N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02b00525d2431f…
2019-07-19 19:46 UTC2019-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023f0d92c62455…
2023-05-13 08:27 UTC2023-05N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02053a50430f4f…
2023-01-26 05:58 UTC2023-01N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019918-001NIX1%LOTION / TOPICALRLD, RS1990-05-02f41ea6bd6efb…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
28160f0d-9f01-4377-a0d7-0b24f9fb86c99b44bf94-62c9-49d8-97ec-cf475824eb352020-07-01WarningsExact identifier
spl id: 28160f0d-9f01-4377-a0d7-0b24f9fb86c9
spl set id: 9b44bf94-62c9-49d8-97ec-cf475824eb35

Reported adverse events (FAERS/openFDA)#

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