Testosterone
- Manufacturer
- ProBlen
- Effective date
- 2020-10-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 02:13:23
Label at a glance#
ProductTestosterone
Active ingredientAVENA SATIVA FLOWERING TOP, BARIUM CARBONATE, MILK THISTLE, TURNERA DIFFUSA LEAFY TWIG, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PORK LIVER, ASIAN GINSENG, NUPHAR LUTEA ROOT, SUS SCROFA TESTICLE, PHOSPHORIC ACID, POPULUS TREMULOIDES LEAF, SAW PALMETTO, SELENIUM, TESTOSTERONE
Label structure8 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients Equal Parts Of: Avena Sativa 1X, Baryta Carbonica 8X, Carduus Mar 1X, Damiana 1X, Hamamelis Virg 1X, Hepar 6X, Korean Ginseng 1X, Nuphar 2X, Orchitinum 6X, Phosphoricum Acidum 12X, Populus Trem 1X, Sabal Serulata 6X, Selenium Metallicum 12X, Testosterone 30X.
INDICATIONS & USAGE SECTION
Indications: Temporarily supports the body to rebalancet tesosterone output. Symptoms may include: poor muscle/fat balance, nervousness, feelings of fatigue, poor sleep.
WARNINGS SECTION
Warnings: Not for use on children. If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness. As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product. In case of overdose, get medical help or contact a Poison Control Center right away.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Directions: Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.
OTHER SAFETY INFORMATION
Tamper Evident: There is a seal around the neck of the bottle. Do not use if seal is broken or missing.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Organic Alcohol 20% v/v, Purified Water
OTC - QUESTIONS SECTION
Distributed By ProBlen (888) 326-2121 www. problen.com
3021 Ridge Rd. Rockwall, TX 75032
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 43853-0021-1
Testosterone
HOMEOPATHIC ORGANOTHERAPY
1.0 FL OZ. (30ML) 20% ALCOHOL
ProBlen
OTC - PURPOSE SECTION
Temporarily supports the body to rebalancet tesosterone output.
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43853-0021-1 | 2022-01-28 | C162847 | 48780-1 | 9d75b9d0-c5f8-f424-e053-dadaa90a57ce | ProBLEN Testosterone |
| 43853-0021-1 | 2020-10-05 | C162847 | 48780-1 | 9d75b9d0-c5f8-f424-e053-dadaa90a57ce | ProBLEN Testosterone |
| 43853-0021-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c5f8-f424-e053-dadaa90a57ce | ProBLEN Testosterone |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43853-0021-1 | Testosterone | 30 mL in 1 BOTTLE, SPRAY | LIQUID | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43853-0021 | TESTOSTERONE (AVENA SATIVA, BARYTA CARBONICA, CARDUUS MAR, DAMIANA, HAMAMELIS VIRG, HEPAR, KOREAN GINSENG, NUPHAR, ORCHITINUM, PHOSPHORICUM ACIDUM, POPULUS TREM, SABAL SERULATA, SELENIUM METALLICUM, TESTOSTERONE.) LIQUID [PROBLEN] | 2 | Legacy NDC, 1 package rows | 20201006_b6b5b283-4b7e-42ee-912c-63b32e1683e1.zip |
Products#
Every source-derived product name is available through these pages.
- Testosterone
- Avena Sativa, Baryta Carbonica, Carduus Mar, Damiana, Hamamelis Virg, Hepar, Korean Ginseng, Nuphar, Orchitinum, Phosphoricum Acidum, Populus Trem, Sabal Serulata, Selenium Metallicum, Testosterone.
- AVENA SATIVA FLOWERING TOP
- BARIUM CARBONATE
- BARIUM CATION
- MILK THISTLE
- TURNERA DIFFUSA LEAFY TWIG
- HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
- PORK LIVER
- ASIAN GINSENG
- NUPHAR LUTEA ROOT
- SUS SCROFA TESTICLE
- PHOSPHORIC ACID
- POPULUS TREMULOIDES LEAF
- SAW PALMETTO
- SELENIUM
- ALCOHOL
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43853-0021 | 43853-0021-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| AVENA SATIVA FLOWERING TOP | MA9CQJ3F7F | ACTIB |
| BARIUM CARBONATE | 6P669D8HQ8 | ACTIB |
| MILK THISTLE | U946SH95EE | ACTIB |
| TURNERA DIFFUSA LEAFY TWIG | RQ2CFA7WWJ | ACTIB |
| HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK | T7S323PKJS | ACTIB |
| PORK LIVER | 6EC706HI7F | ACTIB |
| ASIAN GINSENG | CUQ3A77YXI | ACTIB |
| NUPHAR LUTEA ROOT | 714LIU3V6D | ACTIB |
| SUS SCROFA TESTICLE | KM02613O28 | ACTIB |
| PHOSPHORIC ACID | E4GA8884NN | ACTIB |
| POPULUS TREMULOIDES LEAF | 7IIH57D9E0 | ACTIB |
| SAW PALMETTO | J7WWH9M8QS | ACTIB |
| SELENIUM | H6241UJ22B | ACTIB |
| TESTOSTERONE | 3XMK78S47O | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ad415031-a6bb-4907-98eb-943b94424e84 | b6b5b283-4b7e-42ee-912c-63b32e1683e1 | 2020-10-05 | Warnings | ad415031-a6bb-4907-98eb-943b94424e84 b6b5b283-4b7e-42ee-912c-63b32e1683e1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.