Pulsatilla

Product NDC: 53645-1980
Requested package NDC: 53645-1980-2
11-digit product format: 536451980
Labeler code: 53645
Product ID: 53645-1980_fe1b3122-b69c-46fa-e053-6394a90afd59
Type: HUMAN OTC DRUG
Nonproprietary name: Pulsatilla
Dosage form: GLOBULE
Route: ORAL
Labeler: True Botanica, LLC
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2014-02-03
Substance: PULSATILLA VULGARIS
Active strength: 6 [hp_X]/23g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Pulsatilla
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PULSATILLA VULGARIS	6 [hp_X]/23g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I76KB35JEV	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
61975b02-4357-e6b8-e053-2991aa0a42a3	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53645-1980-3	2021-01-31	C162847	48780-1	ba0f9c33-4989-a910-e053-dadaa90a0b85	Pulsatilla 6X
53645-1980-3	2021-01-29	C162847	48780-1	ba0f9c33-4989-a910-e053-dadaa90a0b85	Pulsatilla 6X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53645-1980-2	Pulsatilla	23 g in 1 BOTTLE	GLOBULE	23		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53645-1980	PULSATILLA GLOBULE [TRUE BOTANICA, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20230621_61975b02-4357-e6b8-e053-2991aa0a42a3.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pulsatilla	PULSATILLA	True Botanica, LLC	61975b02-4357-e6b8-e053-2991aa0a42a3	2023-06-14	Warnings	Exact identifier ndc (package): 53645-1980-2 ndc (product): 53645-1980 ndc11 (package): 53645198002

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53645-1980-2	53645198002	23 g in 1 BOTTLE (53645-1980-2)	23 g	2014-02-03	No	No	Current