D-38

Product NDC
58264-0038
Requested package NDC
58264-0038-1
11-digit product format
582640038
Labeler code
58264
Product ID
58264-0038_2b9ec3c9-bde8-dcf4-e063-6394a90a24ff
Type
HUMAN OTC DRUG
Nonproprietary name
Apis mellifera, Apis mellifera venom, Arsenic trioxide, Bryonia alba Root, and Sulfur
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
APIS MELLIFERA; APIS MELLIFERA VENOM; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; SULFUR
Active strength
6; 12; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
D-38
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA6 [hp_X]/mL
APIS MELLIFERA VENOM12 [hp_X]/mL
ARSENIC TRIOXIDE30 [hp_X]/mL
BRYONIA ALBA ROOT30 [hp_X]/mL
SULFUR30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7S82P3R43ZInternal UNII lookup
76013O881MInternal UNII lookup
S7V92P67HOInternal UNII lookup
T7J046YI2BInternal UNII lookup
70FD1KFU70Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5fff6e4f-a7a4-4975-a8ad-5a3b4685f4aaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0038-12022-06-02C16284748780-19d75b9cf-fa58-f424-e053-dadaa90a57ceD-38
58264-0038-12020-01-31C16284748780-19d75b9cf-fa58-f424-e053-dadaa90a57ceD-38

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0038-1D-3829.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0038D-38 (APIS MELLIFERA, APIS MELLIFERA VENOM, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, AND SULFUR) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_5fff6e4f-a7a4-4975-a8ad-5a3b4685f4aa.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
D-38APIS MELLIFERA, APIS MELLIFERA VENOM, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, AND SULFURDNA Labs, Inc.5fff6e4f-a7a4-4975-a8ad-5a3b4685f4aa2025-01-13WarningsExact identifier
ndc (package): 58264-0038-1
ndc (product): 58264-0038
ndc11 (package): 58264003801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0038-15826400380129.57 mL in 1 BOTTLE, GLASS (58264-0038-1) 29.57 ml1990-01-010000-00-00NoNoCurrent