Milagroso

Manufacturer: Pharmadel LLC
Effective date: 2025-12-04
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 01:20:11

Label at a glance#

ProductMilagroso

Active ingredientMETHYL SALICYLATE

Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: do not use, consult a doctor

Contacts and useful links#

PhoneLabel contact+1-866-359-3478

Label contents#

Full prescribing information#

Active ingredient & Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient	Purpose
Methyl salicylate 10% ..................	External analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with:

simple backache
arthritis
strains
bruises
sprains

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Do not

OTC - DO NOT USE SECTION

apply on wounds or irritated skin
bandage tightly

Stop use and ask doctor immediately if

OTC - STOP USE SECTION

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 12 years of age: do not use, consult a doctor

Other information

OTHER SAFETY INFORMATION

store between 59°- 86°F (15 - 30°C)
do not use if clear seal over jar is broken, torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, D&C yellow #11, lanolin oil, levomenthol, mineral oil, paraffin, petrolatum, propylparaben

Distributed by:

SPL UNCLASSIFIED SECTION

Pharmadel LLC

New Castle, DE 19720

+1-866-359-3478

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

**Milagroso® does not contain bee venom or snake oil but contains an active ingredient that is used as an effective analgesic.**

Milagroso PDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2536330	methyl salicylate 10 % Topical Ointment	PSN	5
2536330	methyl salicylate 0.1 MG/MG Topical Ointment	SCD	5
2536330	methyl salicylate 10 % Topical Ointment	SY	5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55758-378-05	Milagroso	142 g in 1 JAR	OINTMENT	142		5

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Milagroso
Methyl Salicylate
CAMPHOR, (-)-
LEVOMENTHOL
D&C YELLOW NO. 11
PARAFFIN
PROPYLPARABEN
PETROLATUM
SALICYLIC ACID
LANOLIN OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55758-378	55758-378-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAMPHOR, (-)-	213N3S8275	IACT
LEVOMENTHOL	BZ1R15MTK7	IACT
D&C YELLOW NO. 11	44F3HYL954	IACT
PARAFFIN	I9O0E3H2ZE	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PETROLATUM	4T6H12BN9U	IACT
METHYL SALICYLATE	LAV5U5022Y	ACTIB
LANOLIN OIL	OVV5IIJ58F	IACT

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Milagroso	METHYL SALICYLATE	Pharmadel LLC	fdcc8f44-afa0-3af0-e053-6394a90aa46d	2025-12-04	Warnings	Exact identifier ndc (package): 55758-378-05 ndc (product): 55758-378 ndc11 (package): 55758037805 spl id: 452656ff-79e1-0871-e063-6294a90ac49d spl set id: fdcc8f44-afa0-3af0-e053-6394a90aa46d

Reported adverse events (FAERS/openFDA)#

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