Home NDC 61077-127 H-Cold Sores Formula
Product NDC 61077-127
11-digit product format 610770127
Labeler code 61077
Product ID 61077-127_2906ca73-43de-2c24-e063-6294a90a7bf2
Type HUMAN OTC DRUG
Nonproprietary name calendula officinalis, ranunculus bulbosus
Dosage form OIL
Route TOPICAL
Labeler Healing Natural Oils LLC
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2013-11-06
Substance CALENDULA OFFICINALIS FLOWERING TOP; RANUNCULUS BULBOSUS
Active strength 12; 12 [hp_C]/11mL; [hp_C]/11mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base H-Cold Sores Formula
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_C]/11mL RANUNCULUS BULBOSUS 12 [hp_C]/11mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 18E7415PXQ Internal UNII lookup AEQ8NXJ0MB Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61077-127-11 H-Cold Sores Formula 11 mL in 1 BOTTLE, DROPPER OIL 11 8 61077-127-33 H-Cold Sores Formula 33 mL in 1 BOTTLE, DROPPER OIL 33 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CALENDULA OFFICINALIS FLOWERING TOP ACTIVE INGREDIENT 18E7415PXQ H-COLD SORES FORMULA (CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS) OIL [HEALING NATURAL OILS LLC] 6 RANUNCULUS BULBOSUS ACTIVE INGREDIENT AEQ8NXJ0MB H-COLD SORES FORMULA (CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS) OIL [HEALING NATURAL OILS LLC] 6 CALENDULA OFFICINALIS FLOWERING TOP ACTIVE MOIETY 18E7415PXQ H-COLD SORES FORMULA (CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS) OIL [HEALING NATURAL OILS LLC] 6 RANUNCULUS BULBOSUS ACTIVE MOIETY AEQ8NXJ0MB H-COLD SORES FORMULA (CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS) OIL [HEALING NATURAL OILS LLC] 6 CYMBOPOGON MARTINI TOP INACTIVE INGREDIENT 7K1N3UZ6DU H-COLD SORES FORMULA (CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS) OIL [HEALING NATURAL OILS LLC] 6 LAVANDULA ANGUSTIFOLIA FLOWER INACTIVE INGREDIENT 19AH1RAF4M H-COLD SORES FORMULA (CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS) OIL [HEALING NATURAL OILS LLC] 6 LITSEA CUBEBA FRUIT INACTIVE INGREDIENT R3617MQA5Z H-COLD SORES FORMULA (CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS) OIL [HEALING NATURAL OILS LLC] 6 MELALEUCA ALTERNIFOLIA LEAF INACTIVE INGREDIENT G43C57162K H-COLD SORES FORMULA (CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS) OIL [HEALING NATURAL OILS LLC] 6 PELARGONIUM GRAVEOLENS WHOLE INACTIVE INGREDIENT 0E553RP62F H-COLD SORES FORMULA (CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS) OIL [HEALING NATURAL OILS LLC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61077-127 H-COLD SORES FORMULA (CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS) OIL [HEALING NATURAL OILS LLC] 8 Current NDC, Legacy NDC, 2 package rows 20241213_425bc0e8-c884-40cc-90e9-490e50f733c3.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61077-127-11 61077012711 11 mL in 1 BOTTLE, DROPPER (61077-127-11) 11 ml 2013-11-06 0000-00-00 No No Current 61077-127-33 61077012733 33 mL in 1 BOTTLE, DROPPER (61077-127-33) 33 ml 2013-11-06 0000-00-00 No No Current