Cold Sore Rescue

Product NDC
43846-0031
11-digit product format
438460031
Labeler code
43846
Product ID
43846-0031_c8fdf831-1f89-45a8-b490-b21d87580449
Type
HUMAN OTC DRUG
Nonproprietary name
BORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEA
Dosage form
GEL
Route
TOPICAL
Labeler
Peaceful Mountain, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-12-08
Substance
RANUNCULUS BULBOSUS WHOLE; SILICON DIOXIDE; SODIUM BORATE; SODIUM CHLORIDE; SOLANUM DULCAMARA TOP
Active strength
30; 30; 30; 30; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43846-0031-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43846-0031-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43846-0031-21332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Sore Rescue
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM BORATE30 [hp_X]/g
SOLANUM DULCAMARA TOP30 [hp_X]/g
SODIUM CHLORIDE30 [hp_X]/g
RANUNCULUS BULBOSUS WHOLE30 [hp_X]/g
SILICON DIOXIDE30 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
91MBZ8H3QOInternal UNII lookup
KPS1B1162NInternal UNII lookup
451W47IQ8XInternal UNII lookup
AEQ8NXJ0MBInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7fe6ec7-a758-43cf-b46f-c327e0632fb8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

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 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

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

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
Cold Sore RescueBORAX, DULCAMARA, NATRUM MURIATICUM, RANUNCULUS BULBOSUS, SILICEAPeaceful Mountain, Inc.a7fe6ec7-a758-43cf-b46f-c327e0632fb82024-06-13WarningsExact identifier
ndc (product): 43846-0031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43846-0031-1438460031017 g in 1 TUBE7 gHistorical
43846-0031-2438460031021 TUBE in 1 CARTON (43846-0031-2) / 7 g in 1 TUBE (43846-0031-1) 1 tube2014-12-080000-00-00NoNoCurrent