Somaderm

Product NDC
61877-0007
Requested package NDC
61877-0007-1
11-digit product format
618770007
Labeler code
61877
Product ID
61877-0007_39e407af-eee3-419f-9f80-63e924a71e30
Type
HUMAN OTC DRUG
Nonproprietary name
Glandula Suprarenalis Suis, Thyroidinum (Bovine), HGH
Dosage form
GEL
Route
TOPICAL
Labeler
Natural Life Foods Corporation dba XYGENYX
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-09-18
Substance
SUS SCROFA ADRENAL GLAND; THYROID, BOVINE; SOMATROPIN
Active strength
6; 8; 30 [hp_X]/g; [hp_X]/g; [hp_X]/g
Pharmacologic classes
Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Somaderm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUS SCROFA ADRENAL GLAND6 [hp_X]/g
THYROID, BOVINE8 [hp_X]/g
SOMATROPIN30 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
398IYQ16YVInternal UNII lookup
MN18OTN73WInternal UNII lookup
NQX9KB6PCLInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
78032cc1-d529-4d04-8a5c-22fe67ad5dedAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
79c101e4-e5e3-43d7-be20-f7477d1e7556Product name120241230
34b7b043-6d89-4d95-9bed-7f5f2b49e6efProduct name220200325
37e0ae3d-ccb0-0ec8-fae8-e1f0917a8a04Product name220200325
739a54c2-5f56-495a-aa67-4295fbc1cc86Product name220200325
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61877-0007-1Somaderm96 g in 1 BOTTLE, PUMPGEL963

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61877-0007SOMADERM (GLANDULA SUPRARENALIS SUIS, THYROIDINUM (BOVINE), HGH) GEL [NATURAL LIFE FOODS CORPORATION DBA XYGENYX]2Current NDC, Legacy NDC, 1 package rows20190924_78032cc1-d529-4d04-8a5c-22fe67ad5ded.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SomadermGLANDULA SUPRARENALIS SUIS, THYROIDINUM (BOVINE), HGHNatural Life Foods Corporation dba XYGENYX78032cc1-d529-4d04-8a5c-22fe67ad5ded2026-07-16WarningsExact identifier
ndc (package): 61877-0007-1
ndc (product): 61877-0007
ndc11 (package): 61877000701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61877-0007-16187700070196 g in 1 BOTTLE, PUMP (61877-0007-1) 96 g2019-09-180000-00-00NoNoCurrent