NeoRelief for Menstrual Pain and Cramps
- Product NDC
- 58368-003
- 11-digit product format
- 583680003
- Labeler code
- 58368
- Product ID
- 58368-003_4960d9f7-cb96-b6e9-e063-6394a90a9a4d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homeopathic pain relief gel
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- BioLyte Laboratories, LLC
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2018-04-27
- Substance
- APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; BELLIS PERENNIS; BLACK COHOSH; BRYONIA ALBA ROOT; CAULOPHYLLUM THALICTROIDES ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; CYCLAMEN PURPURASCENS TUBER; FRANGULA CALIFORNICA BARK; GELSEMIUM SEMPERVIRENS ROOT; JUNIPERUS SABINA LEAFY TWIG; LILIUM LANCIFOLIUM WHOLE FLOWERING; POTASSIUM CARBONATE; SARACA INDICA BARK; SELENICEREUS GRANDIFLORUS STEM; TILIA X EUROPAEA FLOWER; VIBURNUM OPULUS BARK
- Active strength
- 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 4 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
- Pharmacologic classes
- Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NeoRelief for Menstrual Pain and Cramps
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| APIS MELLIFERA | 4 [hp_X]/g |
| ARNICA MONTANA | 4 [hp_X]/g |
| ATROPA BELLADONNA | 4 [hp_X]/g |
| BELLIS PERENNIS | 4 [hp_X]/g |
| BLACK COHOSH | 4 [hp_X]/g |
| BRYONIA ALBA ROOT | 4 [hp_X]/g |
| CAULOPHYLLUM THALICTROIDES ROOT | 4 [hp_X]/g |
| CITRULLUS COLOCYNTHIS FRUIT PULP | 4 [hp_X]/g |
| CYCLAMEN PURPURASCENS TUBER | 4 [hp_X]/g |
| FRANGULA CALIFORNICA BARK | 4 [hp_X]/g |
| GELSEMIUM SEMPERVIRENS ROOT | 4 [hp_X]/g |
| JUNIPERUS SABINA LEAFY TWIG | 4 [hp_X]/g |
| LILIUM LANCIFOLIUM WHOLE FLOWERING | 4 [hp_X]/g |
| POTASSIUM CARBONATE | 4 [hp_X]/g |
| SARACA INDICA BARK | 4 [hp_X]/g |
| SELENICEREUS GRANDIFLORUS STEM | 4 [hp_X]/g |
| TILIA X EUROPAEA FLOWER | 4 [hp_X]/g |
| VIBURNUM OPULUS BARK | 4 [hp_X]/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7S82P3R43Z, O80TY208ZW, WQZ3G9PF0H, 2HU33I03UY, K73E24S6X9, T7J046YI2B, JTJ6HH6YEH, 23H32AOH17, G728143D8Q, 1LZ13MQR0S, 639KR60Q1Q, Z5BEX9K2G1, X67Z2963PI, BQN1B9B9HA, 341ALE870W, 7114SV0MYK, NHV2K1OUDH, T1UG6H6805 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58368-003-03 | NeoRelief for Menstrual Pain and Cramps | 1 in 1 CARTON | GEL | 1 | | 9 |
| 58368-003-03 | NeoRelief for Menstrual Pain and Cramps | 14.17 g in 1 BOTTLE, PUMP | GEL | 14.17 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58368-003 | NEORELIEF FOR MENSTRUAL PAIN AND CRAMPS (HOMEOPATHIC PAIN RELIEF GEL) GEL [BIOLYTE LABORATORIES, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241012_71c2a2f7-4823-51cb-e053-2995a90a5fb8.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 58368-003-03 | 58368000303 | 1 BOTTLE, PUMP in 1 CARTON (58368-003-03) / 14.17 g in 1 BOTTLE, PUMP | 2018-04-27 | 0000-00-00 | No | No | Current |