Search by Drug Name or NDC
NDC 72854-0352-01 DELSYM 53; 13; 28 mg/g; mg/g; mg/g Details
DELSYM 53; 13; 28 mg/g; mg/g; mg/g
DELSYM is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL, UNSPECIFIED FORM.
Product Information
| NDC | 72854-0352 |
|---|---|
| Product ID | 72854-352_7738b019-5d8a-4cff-be3f-2645e391306c |
| Associated GPIs | |
| GCN Sequence Number | 067594 |
| GCN Sequence Number Description | eucalyptus oil/menthol/camphor OINT ROLON 1.3 %-2.8% TOPICAL |
| HIC3 | L6A |
| HIC3 Description | IRRITANTS/COUNTER-IRRITANTS |
| GCN | 30175 |
| HICL Sequence Number | 019918 |
| HICL Sequence Number Description | EUCALYPTUS OIL/MENTHOL/CAMPHOR |
| Brand/Generic | Brand |
| Proprietary Name | DELSYM |
| Proprietary Name Suffix | NO MESS VAPOR ROLL ON |
| Non-Proprietary Name | camphor (natural), eucalyptus oil, and menthol, unspecified form |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | OINTMENT |
| Route | TOPICAL |
| Active Ingredient Strength | 53; 13; 28 |
| Active Ingredient Units | mg/g; mg/g; mg/g |
| Substance Name | CAMPHOR (NATURAL); EUCALYPTUS OIL; MENTHOL, UNSPECIFIED FORM |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 72854-0352-01 (72854035201)
| NDC Package Code | 72854-352-01 |
|---|---|
| Billing NDC | 72854035201 |
| Package | 1 CONTAINER in 1 CARTON (72854-352-01) / 50 g in 1 CONTAINER |
| Marketing Start Date | 2022-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b168516f-1d7e-4fbd-ab66-9525fdf0d086 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
For external use only
Ask a doctor before use if you have
- chronic cough that lasts such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
When using this product
- do not heat, microwave, or add to hot water or any container where heating water. May cause splattering and result in burns
- do not take by mouth or place in nostrils
- do not bandage tightly
- avoid contact with eyes
- do not apply to wounds or damaged skin
Directions
- see important warnings under "When using this product"
- adults and children 2 years of age and older
- for cough, apply a thick layer on the throat and chest
- cover with a warm, dry cloth if desired
- clothing should be loose about throat and chest to help vapors reach the nose and mouth
- for muscle aches and pains, apply to affected area
- use up to three times daily or as directed by a doctor
- children under 2 years: ask a doctor
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 50 g Container Carton
INGREDIENTS AND APPEARANCE
| DELSYM
NO MESS VAPOR ROLL ON
camphor (natural), eucalyptus oil, and menthol, unspecified form ointment |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - RB Health (US) LLC (081049410) |
Revised: 4/2022
Document Id: 7738b019-5d8a-4cff-be3f-2645e391306c
Set id: b168516f-1d7e-4fbd-ab66-9525fdf0d086
Version: 1
Effective Time: 20220415