Balance Plus Cream

Product NDC
82018-0028
11-digit product format
820180028
Labeler code
82018
Product ID
82018-0028_37e5e4ba-7d94-16de-e063-6394a90a9b17
Type
HUMAN OTC DRUG
Nonproprietary name
estriol,estradiol,progesterone,dhea
Dosage form
CREAM
Route
TRANSDERMAL
Labeler
SHYNE BRANDS/BIOLabs PRO
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-06-01
Substance
ESTRADIOL; ESTRIOL; PRASTERONE; PROGESTERONE
Active strength
60; 240; 1000; 6000 mg/102g; mg/102g; mg/102g; mg/102g
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Balance Plus Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL60 mg/102g
ESTRIOL240 mg/102g
PRASTERONE1000 mg/102g
PROGESTERONE6000 mg/102g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E, FB33469R8E, 459AG36T1B, 4G7DS2Q64Y

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
86ca2ee7-106a-420e-9137-a9ec1af5dbc1Product name120170110
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82018-0028-4Balance Plus Cream102 g in 1 BOTTLE, PUMPCREAM1021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82018-0028-482018002804102 g in 1 BOTTLE, PUMP (82018-0028-4) 102 g2025-06-01NoNoHistorical