CALENDULA OFF
- Product NDC
- 15631-2310
- 11-digit product format
- 156312310
- Labeler code
- 15631
- Product ID
- 15631-2310_de14d02e-c722-4a9a-830c-77627de7bc77
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- CALENDULA OFF
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2016-03-30
- Marketing end
- 0000-00-00
- Substance
- CALENDULA OFFICINALIS FLOWERING TOP
- Active strength
- 1 [hp_X]/g
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7480e90b-004b-ebe4-2243-4f2fefdd9e78 | Product name | 2 | 20260128 |
| 3f158398-73f2-4b90-47d1-5c60e8719a98 | Product name | 9 | 20250721 |
| ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0 | Product name | 2 | 20250117 |
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
| 00358076-c817-430b-b924-11d717dc307c | Product name | 1 | 20160718 |
| 669af5aa-14f3-3df7-f100-5f580ffd43c1 | Product name | 1 | 20140508 |
| 6ff3bab7-2dce-8bea-d7ce-54687f0c01fb | Product name | 1 | 20140508 |
| 8bb82a1c-d0d0-fc27-011f-172e545f0382 | Product name | 1 | 20140508 |
| cb03406d-e223-80bb-67d8-be80f9b6a4f2 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 15631-2310-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-77c2-f424-e053-dadaa90a57ce | 5d25e29a-2465-40c5-9f48-4fe69dd14c44 |
| 15631-2310-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-77c2-f424-e053-dadaa90a57ce | 5d25e29a-2465-40c5-9f48-4fe69dd14c44 |
| 15631-2310-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-77c2-f424-e053-dadaa90a57ce | 5d25e29a-2465-40c5-9f48-4fe69dd14c44 |
| 15631-2310-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-77c2-f424-e053-dadaa90a57ce | 5d25e29a-2465-40c5-9f48-4fe69dd14c44 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 15631-2310-0 | CALENDULA OFF | 1 in 1 CONTAINER | GEL | 1 | 1 | |
| 15631-2310-0 | CALENDULA OFF | 50 g in 1 CONTAINER | GEL | 50 | 1 | |
| 15631-2310-1 | CALENDULA OFF | 1 in 1 CONTAINER | GEL | 1 | 1 | |
| 15631-2310-1 | CALENDULA OFF | 100 g in 1 CONTAINER | GEL | 100 | 1 | |
| 15631-2310-2 | CALENDULA OFF | 1 in 1 CONTAINER | GEL | 1 | 1 | |
| 15631-2310-2 | CALENDULA OFF | 200 g in 1 CONTAINER | GEL | 200 | 1 | |
| 15631-2310-3 | CALENDULA OFF | 500 g in 1 CONTAINER | GEL | 500 | 1 | |
| 15631-2310-3 | CALENDULA OFF | 1 in 1 CONTAINER | GEL | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 15631-2310 | CALENDULA OFF GEL [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC] | 1 | Legacy NDC, 8 package rows | 20160509_5d25e29a-2465-40c5-9f48-4fe69dd14c44.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 15631-2310-0 | 15631231000 | 1 in 1 CONTAINER | Historical | |
| 15631-2310-1 | 15631231001 | 1 in 1 CONTAINER | Historical | |
| 15631-2310-2 | 15631231002 | 1 in 1 CONTAINER | Historical | |
| 15631-2310-3 | 15631231003 | 500 g in 1 CONTAINER | 500 g | Historical |