Australian Dream Back Pain

Product NDC: 61577-8121
Requested package NDC: 61577-8121-4
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 153 · 3,056 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll On	MENTHOL	Chattem, Inc.	aa40c907-eeb5-4fda-b35e-439cbecc178c	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
Icy Hot Performance No-Mess Pain Relief Cream	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	5e3e272a-c001-4f57-9535-521ccc85ae65	2026-07-30	Warnings	Exact identifier application number: M017
Auixudin Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bc7b9e-e2f7-724b-e063-6394a90ab36f	2026-07-29	Warnings	Exact identifier application number: M017
Jinfahe Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bcd9c5-767e-b634-e063-6394a90a2878	2026-07-29	Warnings	Exact identifier application number: M017
Maximun Strength Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Meijer Distribution Inc	d0468514-58ea-4d8f-b634-a65bf95c0316	2026-07-29	Warnings	Exact identifier application number: M017
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	57ca9220-2778-790a-e063-6294a90af506	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine No-Mess plus Lavender	LIDOCAINE HCL	Chattem, Inc.	3948a3d2-ce04-4703-8709-211e75c9c38d	2026-07-29	Warnings	Exact identifier application number: M017
LidoPro	LIDOCAINE AND MENTHOL	Clinic Pharma	cdfd6b39-b430-4e95-a0f7-682cf3d78b52	2026-07-28	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Clinic Pharma	2b4d2105-b7ad-2695-e063-6394a90a999b	2026-07-28	Warnings	Exact identifier application number: M017
Earths Care Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	DLC Laboratories, Inc.	5c3976da-a6cb-4b94-ae41-3e86b1ab13cb	2026-07-28	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Preferred Pharmaceuticals Inc.	9e7568b6-52ae-4f7a-9bfd-503fd80a297e	2026-07-28	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine with Rosemary and Mint	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	9d40bfea-85d0-4943-83e9-0c16e79a011c	2026-07-28	Warnings	Exact identifier application number: M017
KENS PAIN AND ARTHRITIS FORMULA	MENTHOL	Eezaway Relief Inc	35834473-3ad5-41ec-a110-e742aa7e2ee4	2026-07-28	Warnings	Exact identifier application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream	LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57935b64-6e2e-85d0-e063-6394a90a7428	2026-07-27	Warnings	Exact identifier application number: M017
1% Hydrocortisone Anti-itch	1% HYDROCORTISONE ANTI-ITCH	ALAINA HEALTHCARE PRIVATE LIMITED	b8416467-55f7-4e5f-a5cb-3abd3e2bb577	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL 8 LLC	57984bc2-bf1d-c423-e063-6394a90a06ae	2026-07-27	Warnings	Exact identifier application number: M017
Original Pain Relief	TOPICAL ANALGESIC LOTION	Real Time Pain Relief Inc	579bd303-9a50-4d66-e063-6294a90a6141	2026-07-27	Warnings	Exact identifier application number: M017
Lidfix Pain Relief Patch Lidocaine	LIDOCAINE	HETERO HEALTHCARE LIMITED	2149f0e3-1983-4f02-929e-ecd20357f4bb	2026-07-27	Warnings	Exact identifier application number: M017
RectoProtect	LIDOCAINE	Akron Pharma Inc.	1ca7d6cf-85a1-41a6-a07f-cff06a7edfbb	2026-07-27	Warnings	Exact identifier application number: M017

Additional Listing Data#

Finished product: Yes
Brand name base: Australian Dream Back Pain
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3POA0Q644U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
5256a63e-e6da-84c1-e063-6294a90a8dff	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2dae634-14ed-febf-08ee-93196433b5b7	Product name	9	20190614
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
0a5e5249-329b-0cff-e714-77159f193a87	Product name	1	20140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8	Product name	1	20140508
d394f843-7479-dc48-dbd3-232266c5548c	Product name	1	20140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61577-8121-9	Australian Dream Back Pain	266 g in 1 JAR	CREAM	266	8
61577-8121-2	Australian Dream Back Pain	59 g in 1 JAR	CREAM	59	1
61577-8121-3	Australian Dream Back Pain	1 in 1 CARTON	CREAM	1	1
61577-8121-4	Australian Dream Back Pain	119 g in 1 JAR	CREAM	119	1
61577-8121-5	Australian Dream Back Pain	1 in 1 CARTON	CREAM	1	1
61577-8121-8	Australian Dream Back Pain	1 in 1 CARTON	CREAM	1	1
61577-8121-9	Australian Dream Back Pain	266 g in 1 JAR	CREAM	266	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61577-8121	AUSTRALIAN DREAM BACK PAIN (HISTAMINE DIHYDROCHLORIDE) CREAM [SOMBRA COSMETICS, INC.]	8	Current NDC, Legacy NDC, 1 package rows	20240119_6555087a-368a-416c-a91e-d3612cb47968.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3POA0Q644U	HISTAMINE DIHYDROCHLORIDE	56-92-8	HISTAMINE DIHYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1542820	histamine dihydrochloride 0.05 % Topical Cream	PSN	6555087a-368a-416c-a91e-d3612cb47968	8
1542820	histamine dihydrochloride 0.5 MG/ML Topical Cream	SCD	6555087a-368a-416c-a91e-d3612cb47968	8
1542820	histamine dihydrochloride 0.05 % Topical Cream	SY	6555087a-368a-416c-a91e-d3612cb47968	8
1542820	histamine dihydrochloride 0.05 % Topical Cream	PSN	5256a63e-e6da-84c1-e063-6294a90a8dff	1
1542820	histamine dihydrochloride 0.5 MG/ML Topical Cream	SCD	5256a63e-e6da-84c1-e063-6294a90a8dff	1
1542820	histamine dihydrochloride 0.05 % Topical Cream	SY	5256a63e-e6da-84c1-e063-6294a90a8dff	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61577-8121-4	61577812104	119 g in 1 JAR (61577-8121-4)	119 g	2019-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Australian Dream Back Pain Cream	Sombra Cosmetics Inc.	2026-05-21	HUMAN OTC DRUG LABEL	1
Australian Dream Back Pain Cream	Sombra Cosmetics, Inc.	2024-01-18	HUMAN OTC DRUG LABEL	8