FDA.reportPublic FDA data

D-136

Product NDC
58264-0145
11-digit product format
582640145
Labeler code
58264
Product ID
58264-0145_2b9efed7-5d89-16bd-e063-6394a90ac14f
Type
HUMAN OTC DRUG
Nonproprietary name
somatropin, long-(arg3)insulin-like growth factor-i, arsenic trioxide, saw palmetto, platinum, oyster shell calcium carbonate, crude, bos taurus adrenal cortex, bos taurus pituitary gland, posterior, thyroid, unspecified, and bos taurus hypothalamus
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ARSENIC TRIOXIDE; BOS TAURUS ADRENAL CORTEX; BOS TAURUS HYPOTHALAMUS; BOS TAURUS PITUITARY GLAND, POSTERIOR; LONG-(ARG3)INSULIN-LIKE GROWTH FACTOR-I; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PLATINUM; SAW PALMETTO; SOMATROPIN; THYROID, UNSPECIFIED
Active strength
6; 12; 12; 12; 12; 12; 30; 12; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
D-136
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE6 [hp_X]/mL
BOS TAURUS ADRENAL CORTEX12 [hp_X]/mL
BOS TAURUS HYPOTHALAMUS12 [hp_X]/mL
BOS TAURUS PITUITARY GLAND, POSTERIOR12 [hp_X]/mL
LONG-(ARG3)INSULIN-LIKE GROWTH FACTOR-I12 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]/mL
PLATINUM30 [hp_X]/mL
SAW PALMETTO12 [hp_X]/mL
SOMATROPIN12 [hp_X]/mL
THYROID, UNSPECIFIED12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO, OWR1Z96774, S6G2NLH4Y7, 7JM57I419K, M9L22Y19H9, 2E32821G6I, 49DFR088MY, J7WWH9M8QS, NQX9KB6PCL, 0B4FDL9I6P

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
79c101e4-e5e3-43d7-be20-f7477d1e7556Product name120241230
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
34b7b043-6d89-4d95-9bed-7f5f2b49e6efProduct name220200325
37e0ae3d-ccb0-0ec8-fae8-e1f0917a8a04Product name220200325
739a54c2-5f56-495a-aa67-4295fbc1cc86Product name220200325

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0145-12022-06-06C16284748780-19d75b9d0-baca-f424-e053-dadaa90a57ceD-136
58264-0145-12020-01-31C16284748780-19d75b9d0-baca-f424-e053-dadaa90a57ceD-136

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0145-1D-13629.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0145D-136 (SOMATROPIN, LONG-(ARG3)INSULIN-LIKE GROWTH FACTOR-I, ARSENIC TRIOXIDE, SAW PALMETTO, PLATINUM, OYSTER SHELL CALCIUM CARBONATE, CRUDE, BOS TAURUS ADRENAL CORTEX, BOS TAURUS PITUITARY GLAND, POSTERIOR, THYROID, UNSPECIFIED, AND BOS TAURUS HYPOTHALAMUS) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_d94be950-ce16-4c55-bbb3-af3f9c4d29d6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0145-15826401450129.57 mL in 1 BOTTLE, GLASS (58264-0145-1) 29.57 ml1990-01-010000-00-00NoNoCurrent