FDA.reportPublic FDA data

Dr. Freds MIRACLE RUB

Product NDC
65121-403
11-digit product format
651210403
Labeler code
65121
Product ID
65121-403_9611d21d-298b-264a-e053-2995a90a910e
Type
HUMAN OTC DRUG
Nonproprietary name
HISTAMINE DIHYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Pure Source, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-06-06
Marketing end
0000-00-00
Substance
HISTAMINE DIHYDROCHLORIDE
Active strength
0 mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65121-403DDiscontinued by firm2026-08-17
excluded packagepackage65121-40365121-403-25DDiscontinued by firm2026-08-17

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65121-403-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65121-403-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65121-403-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65121-403-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65121-403-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65121-403-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65121-403-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65121-403-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65121-403-250efc9e666f02…f202fb6c5f17…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644UDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
HISTAMINEACTIVE MOIETY820484N8I3DR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70DR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
CETEARYL OLIVATEINACTIVE INGREDIENT58B69Q84JODR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201DR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4DR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
ROYAL JELLYINACTIVE INGREDIENTL497I37F0CDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GRDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDR. FREDS MIRACLE RUB (HISTAMINE DIHYDROCHLORIDE) CREAM [PURE SOURCE INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65121-403-25651210403251 BOTTLE in 1 CARTON (65121-403-25) > 118 mL in 1 BOTTLE1 bottle2017-02-090000-00-00NoNoCurrent