FDA.reportPublic FDA data

NDC 43846-0031-01 - Cold Sore Rescue

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
43846-0031
Requested NDC
43846-0031-01
Package NDCs from labels
43846-0031-1, 43846-0031-2, 43846-0031-01
Manufacturer
Peaceful Mountain, Inc. | Apotheca Company
Effective date
2024-06-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cold Sore Rescue - Peaceful Mountain, Inc. | Apotheca CompanyPeaceful Mountain, Inc. | Apotheca Company2024-06-13HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-06-13DRUG FACTS:
2024-01-30DRUG FACTS:
2020-04-24DRUG FACTS:
2020-01-31DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43846-0031-1Cold Sore Rescue7 g in 1 TUBEGEL76
43846-0031-2Cold Sore Rescue1 in 1 CARTONGEL16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43846-0031COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]6Current NDC, Legacy NDC, 2 package rows20240615_a7fe6ec7-a758-43cf-b46f-c327e0632fb8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RANUNCULUS BULBOSUSACTIVE INGREDIENTAEQ8NXJ0MBCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SODIUM BORATEACTIVE INGREDIENT91MBZ8H3QOCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SOLANUM DULCAMARA TOPACTIVE INGREDIENTKPS1B1162NCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
BORATE IONACTIVE MOIETY44OAE30D22COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
RANUNCULUS BULBOSUSACTIVE MOIETYAEQ8NXJ0MBCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SOLANUM DULCAMARA TOPACTIVE MOIETYKPS1B1162NCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
ACHILLEA MILLEFOLIUM FLOWERINACTIVE INGREDIENTYQR8R0SQEACOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ECOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839XCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
LARREA TRIDENTATA TOPINACTIVE INGREDIENTPK0TXD049PCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4MCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE9219COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
OREGANOINACTIVE INGREDIENT0E5AT8T16UCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764ODCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
PHYTOLACCA AMERICANA FRUITINACTIVE INGREDIENTWE63661499COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
PHYTOLACCA AMERICANA ROOTINACTIVE INGREDIENT11E6VI8VEGCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33ACOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5RCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H7COLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
ST. JOHN'S WORTINACTIVE INGREDIENTUFH8805FKACOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLD SORE RESCUE (BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA) GEL [PEACEFUL MOUNTAIN, INC.]1

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 4 of 253 · 5,042 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Swisher Instant Hand Sanitizer GelALCOHOLEcolab Inc.1f84e842-ece4-4eb7-9ccf-d86cec78dbf22026-08-31WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a4fb4b6-ba9e-5b82-e063-6294a90a47342026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a503581-061b-0050-e063-6294a90af48a2026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk-Christmas Rose and Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a50402b-e4d7-3c0b-e063-6394a90a5e522026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk -Bourbon Peacan and MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a508fad-c7a4-82e8-e063-6294a90a0de12026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Beaded Wristlet - EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f160d3-7e42-ef07-e063-6394a90a6f8f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,4pk with Silicone Case,Cherry Blossom /Gardenia /Lavender Vanilla/ Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2ab646-2dba-5111-e063-6394a90acc4f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Strawberry Dream/ Berry BlissALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2b50a2-6ee2-04d4-e063-6294a90a1c652026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Cherry and Honey VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2c11e6-a105-5362-e063-6394a90a132f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Glitter Silicone Case,2pk Vanilla Chai and EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59ef14d6-1a40-ea3c-e063-6394a90af4422026-08-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Glitter Silicone Case , 2pk Champagne Toast and Sparkling PomegranateALCOHOLShenzhen Lantern Scicence Co.,Ltd.597530cb-03f6-b72d-e063-6394a90a0d6c2026-08-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,4pk with Silicone Case,Rosewater/Raspberry Fizz/Strawberry Vanilla/Pink PeonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f1521c-ad5c-e2d6-e063-6394a90a4e2b2026-08-28WarningsExact identifier
unii: 3K9958V90M
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA Inc.5dc007a2-61fa-4115-a82c-1aa489a6bd392026-08-27WarningsExact identifier
unii: 3K9958V90M
Sore ThroatCAPSICUM ANNUUM, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, PHYTOLACCA DECANDRA, THYMUS VULGARIS, ZINCUM GLUCONICUMNaturalCare4ae3625e-6d9c-46b3-82a8-dcc4eedc1f3d2026-08-27WarningsExact identifier
unii: 11E6VI8VEG
Dehydrated AlcoholALCOHOLBreckenridge Pharmaceutical Incbe10b253-d72a-4f57-aa27-94c70ae8aed32026-08-27Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
Surface x Cutie Pals Hand Sanitizer SurpriseALCOHOLI WORLD, LLC2e274b4a-953e-47ce-aa73-81576a4677102026-08-27WarningsExact identifier
unii: 3K9958V90M
Surface x Cutie Pals Hand Sanitizer Cherry PieALCOHOLI WORLD, LLC771fdce8-c633-4592-9bbf-5985c2536f2d2026-08-27WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Sparkling Watermelon/ Pomegranate RaspberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2a89f4-838e-e3ea-e063-6294a90a1ac22026-08-27WarningsExact identifier
unii: 3K9958V90M
Smart Care LAVENDER VANILLA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.549c6774-a785-4a12-9ff9-9ba17befcc392026-08-27WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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