FDA.reportPublic FDA data

Australian Dream Back Pain

Product NDC
61577-8121
11-digit product format
615778121
Labeler code
61577
Product ID
61577-8121_5256a63e-e6db-84c1-e063-6294a90a8dff
Type
HUMAN OTC DRUG
Nonproprietary name
Histamine Dihydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sombra Cosmetics Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-29
Substance
HISTAMINE DIHYDROCHLORIDE
Active strength
.0005 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 productproduct61577-8121IInactivated by FDA2026-09-14
excluded packagepackage61577-812161577-8121-9IInactivated by FDA2026-09-14

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
Australian Dream Back Pain
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HISTAMINE DIHYDROCHLORIDE.0005 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3POA0Q644UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1542820Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5256a63e-e6da-84c1-e063-6294a90a8dffAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-8121-9Australian Dream Back Pain266 g in 1 JARCREAM2668
61577-8121-2Australian Dream Back Pain59 g in 1 JARCREAM591
61577-8121-3Australian Dream Back Pain1 in 1 CARTONCREAM11
61577-8121-4Australian Dream Back Pain119 g in 1 JARCREAM1191
61577-8121-5Australian Dream Back Pain1 in 1 CARTONCREAM11
61577-8121-8Australian Dream Back Pain1 in 1 CARTONCREAM11
61577-8121-9Australian Dream Back Pain266 g in 1 JARCREAM2661

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-8121AUSTRALIAN DREAM BACK PAIN (HISTAMINE DIHYDROCHLORIDE) CREAM [SOMBRA COSMETICS, INC.]8Current NDC, Legacy NDC, 1 package rows20240119_6555087a-368a-416c-a91e-d3612cb47968.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 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
application number: M017
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
application number: M017
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
NeuroNesic Pain Relieving CreamCAPSAICINBlaine Labs Inc.7107c13d-bf59-4c0a-84fe-725a9fca26912026-09-04WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsExact identifier
application number: M017
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
application number: M017
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
application number: M017
Komxsum LIDOCAINE CreamLIDOCAINE 4% CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9feae0-9be4-e736-e063-6294a90abe552026-09-03WarningsExact identifier
application number: M017
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
application number: M017
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
application number: M017
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact identifier
application number: M017
Ramedica Herbal Wonder BalmCAMPHOR, MENTHOLRamedicare Sdn. Bhd.cfb2ea0e-a1f6-4fdf-b866-346bbe78788f2026-09-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1542820histamine dihydrochloride 0.05 % Topical CreamPSN6555087a-368a-416c-a91e-d3612cb479688
1542820histamine dihydrochloride 0.5 MG/ML Topical CreamSCD6555087a-368a-416c-a91e-d3612cb479688
1542820histamine dihydrochloride 0.05 % Topical CreamSY6555087a-368a-416c-a91e-d3612cb479688
1542820histamine dihydrochloride 0.05 % Topical CreamPSN5256a63e-e6da-84c1-e063-6294a90a8dff1
1542820histamine dihydrochloride 0.5 MG/ML Topical CreamSCD5256a63e-e6da-84c1-e063-6294a90a8dff1
1542820histamine dihydrochloride 0.05 % Topical CreamSY5256a63e-e6da-84c1-e063-6294a90a8dff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-8121-26157781210259 g in 1 JAR (61577-8121-2) 59 g2019-12-100000-00-00NoNoCurrent
61577-8121-3615778121031 JAR in 1 CARTON (61577-8121-3) / 59 g in 1 JAR (61577-8121-2) 1 jar2023-09-29NoNoCurrent
61577-8121-461577812104119 g in 1 JAR (61577-8121-4) 119 g2019-12-100000-00-00NoNoCurrent
61577-8121-5615778121051 JAR in 1 CARTON (61577-8121-5) / 119 g in 1 JAR (61577-8121-4) 1 jar2026-02-20NoNoCurrent
61577-8121-8615778121081 JAR in 1 CARTON (61577-8121-8) / 266 g in 1 JAR (61577-8121-9) 1 jar2024-01-18NoNoCurrent
61577-8121-961577812109266 g in 1 JAR266 gHistorical